IVA ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症386

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2021-000694-85-DK
(EUCTR)
17/03/202227/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Denmark;Australia;Germany;Netherlands;Norway;Sweden
2NCT05274269
(ClinicalTrials.gov)
March 20221/3/2022Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del MutationA Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR MutationCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVA;Other: Placebo (matched to ELX/TEZ/IVA);Other: Placebo (matched to IVA)Vertex Pharmaceuticals IncorporatedNULLNot yet recruiting6 YearsN/AAll270Phase 3NULL
3EUCTR2021-005320-38-ES
(EUCTR)
21/01/202201/12/2021Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del MutationA Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg ELX/50mg TEZ /75mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 75-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
270Phase 3France;Portugal;Belgium;Spain;Austria;Netherlands;Germany;Switzerland;Italy
4EUCTR2021-000712-31-SE
(EUCTR)
18/01/202222/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden
5NCT05153317
(ClinicalTrials.gov)
January 17, 202229/11/2021Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and OlderA Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and OlderCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLEnrolling by invitation2 YearsN/AAll70Phase 3United States
6EUCTR2021-000712-31-PT
(EUCTR)
14/01/202216/11/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Portugal;Czechia;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden
7NCT05111145
(ClinicalTrials.gov)
January 14, 202227/10/2021A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF)A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic FibrosisCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLEnrolling by invitation12 YearsN/AAll195Phase 3Australia;Spain
8EUCTR2021-000712-31-DE
(EUCTR)
12/01/202223/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden
9EUCTR2021-000694-85-IT
(EUCTR)
21/12/202115/10/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation - A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous fo Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: [VX-770]
INN or Proposed INN: ivacaftor
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: [VX-121/TEZ/D-IVA]
INN or Proposed INN: tezacaftor
INN or Proposed INN: deutivacaftor
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: [ELX/TEZ/IVA]
INN or Proposed INN: elexacaftor
INN or Proposed INN: tezacaftor
INN or Proposed INN: ivacaftor
VERTEX PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
10EUCTR2021-000694-85-DE
(EUCTR)
20/12/202127/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
11EUCTR2021-000694-85-NL
(EUCTR)
09/12/202127/10/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Norway;Sweden
12EUCTR2021-000694-85-GR
(EUCTR)
07/12/202119/10/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Norway;Sweden
13EUCTR2021-000694-85-NO
(EUCTR)
03/12/202120/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden
14EUCTR2020-004885-21-ES
(EUCTR)
18/11/202119/10/2021A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects With Cystic FibrosisA Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Kaftrio
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kaftrio
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
143Phase 3Czechia;Czech Republic;Belgium;Spain;Netherlands
15EUCTR2020-004885-21-CZ
(EUCTR)
12/11/202131/08/2021A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects With Cystic FibrosisA Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Kaftrio
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kaftrio
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
143Phase 3Czechia;Czech Republic;Canada;Spain;Belgium;Australia;Netherlands
16EUCTR2021-000694-85-SE
(EUCTR)
10/11/202122/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
17NCT05076149
(ClinicalTrials.gov)
October 27, 202129/9/2021A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationCystic FibrosisDrug: VX-121/TEZ/D-IVA;Drug: ELX/TEZ/IVA;Drug: IVA;Drug: Placebo (matched to VX-121/TEZ/D-IVA);Drug: Placebo (matched to ELX/TEZ/IVA);Drug: Placebo (matched to IVA)Vertex Pharmaceuticals IncorporatedNULLRecruiting12 YearsN/AAll550Phase 3United States;Australia;Canada;France;Germany;Italy;Netherlands;United Kingdom
18NCT04969224
(ClinicalTrials.gov)
October 12, 20219/7/2021A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Subjects With Cystic Fibrosis (CF)A Phase 3b Open-label Study Evaluating the Effects of Elexacaftor/Tezacaftor/Ivacaftor on Cough and Physical Activity in Cystic Fibrosis Subjects 12 Years of Age and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)Cystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLRecruiting12 YearsN/AAll100Phase 3Australia;Belgium;Canada;Spain
19EUCTR2020-002251-38-DE
(EUCTR)
28/09/202120/07/2021Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 YearsA Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 80mg ELX / 40mg TEZ / 60mg IVA
Product Code: ELX/TEZ/IVA
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Product Name: IVACAFTOR 59,5mg
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100g ELX / 50mg TEZ / 75mg IVA
INN or Proposed INN: Elexacaftor
INN or Proposed INN: Tezacaftor
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: IVACAFTOR 75mg
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 3United States;Germany;United Kingdom
20NCT05033080
(ClinicalTrials.gov)
September 14, 202126/8/2021A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)Cystic FibrosisDrug: VX-121/TEZ/D-IVA;Drug: ELX/TEZ/IVA;Drug: IVA;Drug: Placebo (matched to VX-121/TEZ/D-IVA);Drug: Placebo (matched to ELX/TEZ/IVA);Drug: Placebo (matched to IVA)Vertex Pharmaceuticals IncorporatedNULLRecruiting12 YearsN/AAll400Phase 3United States;Czechia;Germany;United Kingdom
21EUCTR2021-001628-16-ES
(EUCTR)
30/07/202120/07/2021A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Subjects with Cystic Fibrosis (CF)A Phase 3b Open-label Study Evaluating the Effects of Elexacaftor/Tezacaftor/Ivacaftor on Cough and Physical Activity in Cystic Fibrosis Subjects 12 Years of Age and Older Who Are Heterozygous for the F508delMutation and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 3Canada;Belgium;Spain;Australia
22NCT04702360
(ClinicalTrials.gov)
June 23, 20216/1/2021ELX/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients With at Least One F508del MutationELX/TEZ/IVA Expanded Access Program for Patients 6 Through 11 Years of Age With Cystic Fibrosis Who Have At Least One F508del MutationCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLApproved for marketing6 Years11 YearsAllNULL
23EUCTR2020-005224-12-NL
(EUCTR)
01/05/202104/01/2021Kaftrio in cystic fibrosis patients currently using tacrolimus, a drug drug interaction studyElexacaftor/tezacaftor/ivacaftor in patients with cystic fibrosis using tacrolimus, a drug - drug interaction study - Kaftac cystic fibrosis patients;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: KaftrioHaga Teaching HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
5Phase 4Netherlands
24EUCTR2020-001404-42-DK
(EUCTR)
09/02/202105/10/2020A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypesA Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
108Phase 3France;Canada;Spain;Australia;Denmark;Israel;Netherlands;Germany;United Kingdom;Switzerland
25NCT04599465
(ClinicalTrials.gov)
January 18, 202121/10/2020A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects With Abnormal Glucose MetabolismCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 YearsN/AAll69Phase 3Spain;Netherlands;Italy;France;Czechia;Belgium;Australia
26NCT04545515
(ClinicalTrials.gov)
January 11, 20213/9/2020A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF GenotypesA Phase 3b Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)Cystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting6 YearsN/AAll120Phase 3Australia;Canada;Denmark;France;Germany;Israel;Netherlands;Spain;Switzerland;United Kingdom
27EUCTR2020-001404-42-NL
(EUCTR)
06/01/202107/10/2020A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypesA Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
108Phase 3France;Canada;Spain;Denmark;Australia;Israel;Germany;Netherlands;United Kingdom;Switzerland
28EUCTR2020-003170-44-IT
(EUCTR)
14/12/202015/06/2021NAA Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic FibrosisSubjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770)
Product Code: [NA]
INN or Proposed INN: Elexacaftor
INN or Proposed INN: Tezacaftor
INN or Proposed INN: IVACAFTOR
Trade Name: Ivacaftor
Product Name: 150mg IVACAFTOR
Product Code: [VX-770]
INN or Proposed INN: IVACAFTOR
VERTEX PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Czechia;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy
29EUCTR2020-003170-44-CZ
(EUCTR)
03/12/202022/10/2020A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose MetabolismA Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770)
INN or Proposed INN: Elexacaftor
INN or Proposed INN: Tezacaftor
INN or Proposed INN: IVACAFTOR
Trade Name: Ivacaftor
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 3France;Czechia;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy
30NCT04537793
(ClinicalTrials.gov)
November 19, 202028/8/2020Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 YearsA Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Through 5 Years of AgeCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting2 Years5 YearsAll93Phase 3United States;Australia;Canada;Germany;United Kingdom
31NCT04509050
(ClinicalTrials.gov)
November 18, 20206/8/2020Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young ChildrenA Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN Study)Cystic FibrosisDrug: Ivacaftor or elexacaftor/tezacaftor/ivacaftorSonya HeltsheCystic Fibrosis Foundation;University of Washington;University of Alabama at BirminghamActive, not recruitingN/A5 YearsAll210United States
32EUCTR2019-003554-86-FR
(EUCTR)
29/10/202002/04/2020A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypesA Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
Product Name: 150-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
108Phase 3France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland
33EUCTR2020-001404-42-GB
(EUCTR)
12/10/202025/08/2020A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypesA Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) - Phase 3b Open-label Study of ELX/TEZ/IVA in subjects 6 years & older Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
108Phase 3Israel;Netherlands;Germany;Switzerland;United Kingdom;France;Canada;Spain;Denmark;Australia
34EUCTR2019-003554-86-DK
(EUCTR)
19/08/202027/03/2020A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypesA Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
Product Name: 150-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
108Phase 3Germany;United Kingdom;Switzerland;France;Canada;Spain;Australia;Denmark;Israel;Netherlands
35EUCTR2019-003554-86-DE
(EUCTR)
14/08/202012/03/2020A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypesA Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
Product Name: 150-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
108Phase 3France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland
36EUCTR2019-003554-86-NL
(EUCTR)
28/07/202001/05/2020A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypesA Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
Product Name: 150-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
108Phase 3France;Canada;Spain;Denmark;Australia;Israel;Germany;Netherlands;United Kingdom;Switzerland
37NCT04058210
(ClinicalTrials.gov)
July 21, 202013/8/2019VX-445/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients Heterozygous for F508del Mutation and a Minimal Function Mutation (F/MF Genotypes)VX-445/TEZ/IVA Triple Combination Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function CFTR MutationCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLApproved for marketing12 YearsN/AAllNULL
38NCT04353817
(ClinicalTrials.gov)
June 19, 202016/4/2020A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF GenotypesA Phase 3b, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)Cystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVA;Other: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted6 Years11 YearsAll121Phase 3Australia;Canada;Denmark;France;Germany;Israel;Netherlands;Spain;Switzerland;United Kingdom
39NCT04362761
(ClinicalTrials.gov)
May 4, 202022/4/2020A Study Evaluating the Long-Term Safety of Elexacaftor Combination TherapyA Phase 3b Open-label Extension Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis SubjectsCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 YearsN/AAll172Phase 3Australia;Belgium;Germany;United Kingdom
40EUCTR2019-003554-86-GB
(EUCTR)
01/05/202001/04/2020A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypesA Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) - Phase 3b Study of ELX/TEZ/IVA in CF subjects 6 Through 11 Years of Age Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
Product Name: 150-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
108Phase 3France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;Switzerland;United Kingdom
41EUCTR2019-003455-11-DE
(EUCTR)
08/04/202009/12/2019Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis SubjectsA Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Trikafta
Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: SUB185183
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: SUB185183
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: Ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
158Phase 3Belgium;Australia;Germany;United Kingdom
42EUCTR2019-003455-11-BE
(EUCTR)
17/03/202023/12/2019Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis SubjectsA Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Kaftrio
Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: SUB185183
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg
Product Code: ELX/TEZ/IVA
INN or Proposed INN: SUB185183
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: Ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
158Phase 3Belgium;Australia;Germany;United Kingdom
43EUCTR2019-001827-11-IE
(EUCTR)
28/02/202020/12/2019Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and OlderA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445 / TEZ / IVA FDC
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: VX-445 / TEZ / IVA FDC
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
Product Name: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
56Phase 3United States;Canada;Ireland;Australia;United Kingdom
44NCT04235140
(ClinicalTrials.gov)
February 24, 202015/1/2020Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment InitiationA Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment InitiationCystic FibrosisDrug: LUM/IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 MonthsN/AAll52Phase 3United States;Canada
45NCT04183790
(ClinicalTrials.gov)
February 17, 202028/11/2019Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and OlderA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and OlderCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting6 YearsN/AAll64Phase 3United States;Australia;Canada;Ireland;United Kingdom
46EUCTR2019-000833-37-DE
(EUCTR)
23/01/202027/06/2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Trikafta
Product Name: 100-mg ELX (VX-455) / 50-mg TEZ / 75-mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
47EUCTR2019-000833-37-NL
(EUCTR)
22/01/202017/09/2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy
48EUCTR2018-002835-76-NL
(EUCTR)
22/01/202017/09/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy
49EUCTR2019-003455-11-GB
(EUCTR)
17/01/202009/12/2019Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis SubjectsA Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: SUB185183
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
158 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelgium;Australia;Germany;United Kingdom
50EUCTR2018-004652-38-IE
(EUCTR)
15/01/202017/06/2019A Study Evaluating the Long-term Safety of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy Cystic Fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 /50-mg TEZ/75-mg
Product Code: VX-445 /TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
481Phase 3United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Germany;United Kingdom;Switzerland
51NCT04058366
(ClinicalTrials.gov)
December 5, 201914/8/2019Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)Cystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 YearsN/AAll251Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;United Kingdom
52NCT04135495
(ClinicalTrials.gov)
November 25, 201916/8/2019A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X AlleleA Phase 2 Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients With Cystic Fibrosis With at Least One G542X AlleleCystic FibrosisDrug: ELX-02;Drug: IvacaftorEloxx Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll16Phase 2United States;Canada
53EUCTR2019-000833-37-ES
(EUCTR)
19/11/201909/08/2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
54EUCTR2018-000966-12-DE
(EUCTR)
18/11/201925/06/2019A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients with Cystic FibrosisA Phase 2 Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients with Cystic Fibrosis with at Least One G542X Allele Cystic fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Code: ELX-02
INN or Proposed INN: Not Assigned
Trade Name: Kalydeco
Product Name: Kalydeco
INN or Proposed INN: Ivacaftor
Eloxx Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 2Australia;Israel;Germany
55EUCTR2018-004652-38-GB
(EUCTR)
06/11/201919/06/2019A Study Evaluating the Long-term Safety of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy Cystic Fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 /50-mg TEZ/75-mg
Product Code: VX-445 /TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
481Phase 3United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Germany;Switzerland;United Kingdom
56EUCTR2018-002835-76-GB
(EUCTR)
29/10/201927/06/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
57EUCTR2019-000833-37-GB
(EUCTR)
29/10/201927/06/2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3France;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
58EUCTR2019-000833-37-IE
(EUCTR)
21/10/201927/06/2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
59EUCTR2018-002835-76-IE
(EUCTR)
21/10/201928/06/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
60EUCTR2018-002835-76-DE
(EUCTR)
21/10/201903/07/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
61EUCTR2018-004652-38-DK
(EUCTR)
18/10/201928/06/2019A Study Evaluating the Long-term Safety of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy Cystic Fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 /50-mg TEZ/75-mg
Product Code: VX-445 /TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
506Phase 3United States;Canada;Spain;Poland;Ireland;Australia;Denmark;Israel;Germany;United Kingdom;Switzerland
62EUCTR2019-000833-37-DK
(EUCTR)
17/10/201909/07/2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3France;United States;Canada;Spain;Belgium;Ireland;Australia;Denmark;Netherlands;Germany;United Kingdom;Italy
63EUCTR2018-002835-76-DK
(EUCTR)
16/10/201909/07/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United Kingdom;Italy;Germany;Netherlands;Denmark;Australia;Ireland;Spain;Belgium;Canada;United States;France
64EUCTR2018-001695-38-GB
(EUCTR)
09/10/201919/08/2019Evaluation of VX-445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 YearsA Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445 / TEZ / IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: VX-445 / TEZ / IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Product Name: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
56Phase 3United States;Canada;Ireland;Australia;United Kingdom
65EUCTR2019-000833-37-IT
(EUCTR)
08/10/201922/01/2021A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) - NA Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75- mg IVA FDC
Product Code: [VX-445/TEZ/IVA]
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: ivacaftor
Product Code: [VX-770]
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
VERTEX PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
66EUCTR2018-002835-76-IT
(EUCTR)
04/10/201912/02/2021A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF)Subjects Heterozygous for F508del and a Gating or Residual FunctionMutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating theEfficacy and Safety of VX-445 Combination Therapy in Subjects With CysticFibrosis Who Are Heterozygous for the F508del Mutation and a Gating orResidual Function Mutation (F/G and F/RF Genotypes) - NA Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75- mg IVA FDC
Product Code: [VX-445/TEZ/IVA]
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Name: VX-661 / VX-770
Product Code: [VX-661 / VX-770]
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: [VX-770]
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
VERTEX PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
250Phase 3France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
67NCT04105972
(ClinicalTrials.gov)
October 3, 201924/9/2019A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508delA Phase 3b, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508delCystic FibrosisDrug: ELX/TEZ/IVA;Drug: TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll176Phase 3Australia;Belgium;Germany;United Kingdom
68EUCTR2019-001735-31-GB
(EUCTR)
13/09/201924/06/2019A study to evaluate the safety and efficacy of VX-445 / Tezacaftor / Ivacaftor in patients suffering from Cystic FibrosisA Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del - A Study Evaluating the Efficacy & Safety of VX-445/Tezacaftor/Ivacafto in Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: ELEXACAFTOR
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
158Phase 3Belgium;Australia;Germany;United Kingdom
69EUCTR2018-003970-28-NL
(EUCTR)
12/09/201909/05/2019A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Deutivacaftor
Product Code: VX-561
INN or Proposed INN: DEUTIVACAFTOR
INN or Proposed INN: DEUTIVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;Belgium;Ireland;Australia;Germany;Netherlands;United Kingdom
70NCT04056702
(ClinicalTrials.gov)
September 5, 201927/7/2019Impact of Triple Combination CFTR Therapy on Sinus Disease.Impact of Elexacaftor-tezacaftor-ivacaftor Triple Combination CFTR Therapy on Sinus Disease: Quantitative Sinus Computed Tomography, Patient Reported Outcomes and Cellular and Molecular ChangesCystic FibrosisDrug: Elexacaftor-tezacaftor-ivacaftor exposureJennifer Taylor-CousarCystic Fibrosis FoundationRecruiting18 Years89 YearsAll31United States
71NCT04006873
(ClinicalTrials.gov)
September 3, 20192/7/2019Gut Imaging for Function & Transit in Cystic Fibrosis Study 2A Randomised Crossover Pilot Study of the Effects of Tezacaftor/Ivacaftor and Ivacaftor on Gastrointestinal Function Using Magnetic Resonance Imaging Parameters in People With Cystic FibrosisCystic FibrosisDrug: Tezacaftor/Ivacaftor + Ivacaftor;Drug: Placebo oral tabletNottingham University Hospitals NHS TrustVertex Pharmaceuticals Incorporated;Cystic Fibrosis Foundation;Cystic Fibrosis Trust;University of Nottingham;Nottingham University Hospitals CharityCompleted12 Years40 YearsAll12Phase 2United Kingdom
72EUCTR2019-000833-37-FR
(EUCTR)
02/09/201912/07/2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
250Phase 3United States;France;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
73NCT04058353
(ClinicalTrials.gov)
August 28, 201914/8/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)Cystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVA;Drug: TEZ/IVAVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll271Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Israel;Italy;Netherlands;Spain;United Kingdom
74EUCTR2018-003970-28-DE
(EUCTR)
12/08/201921/05/2019A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Deutivacaftor
Product Code: VX-561
INN or Proposed INN: DEUTIVACAFTOR
Product Name: Deutivacaftor
Product Code: VX-561
INN or Proposed INN: DEUTIVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom
75NCT04043806
(ClinicalTrials.gov)
August 9, 201931/7/2019A Study Evaluating the Long-term Safety of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic FibrosisCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 YearsN/AAll458Phase 3United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom
76EUCTR2017-004134-29-DE
(EUCTR)
12/07/201905/03/2018A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/ TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
77EUCTR2018-002496-18-NL
(EUCTR)
08/07/201913/02/2019A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121
INN or Proposed INN: N/A
Other descriptive name: VX-121
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: TEZACAFTOR
Product Name: VX-561
INN or Proposed INN: N/A
Other descriptive name: VX-561
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
108Phase 2United States;Portugal;Germany;Netherlands;United Kingdom
78EUCTR2018-003970-28-BE
(EUCTR)
04/07/201923/04/2019A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Deutivacaftor
Product Code: VX-561
INN or Proposed INN: DEUTIVACAFTOR
Product Name: Deutivacaftor
Product Code: VX-561
INN or Proposed INN: DEUTIVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom
79EUCTR2018-003970-28-GB
(EUCTR)
18/06/201917/04/2019A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Deutivacaftor
Product Code: VX-561
INN or Proposed INN: DEUTIVACAFTOR
INN or Proposed INN: DEUTIVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom
80EUCTR2018-002496-18-PT
(EUCTR)
20/05/201905/02/2019A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121
INN or Proposed INN: N/A
Other descriptive name: VX-121
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: TEZACAFTOR
Product Name: VX-561
INN or Proposed INN: N/A
Other descriptive name: VX-561
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
108Phase 2United States;Portugal;Netherlands;Germany;United Kingdom
81EUCTR2019-001314-41-NL
(EUCTR)
06/05/201906/05/2019This study investigates the effect of switching from Orkambi treatment to Symkevi. In particuar we want to investigate the effect of the switch on the uptake, concentration in the blood an degradation of ivacaftor.Kinetics of ivacaftor at Switch Orkambi Symkevi study - SOS Cystic fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Orkambi: contains lumacaftor and ivacaftor
Product Name: Orkambi
Trade Name: Symkevi
Product Name: Symkevi
Trade Name: Kalydeco
Product Name: Kalydeco
NULLNot RecruitingFemale: yes
Male: yes
100Phase 4Netherlands
82EUCTR2018-002496-18-DE
(EUCTR)
02/05/201928/01/2019A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121
INN or Proposed INN: N/A
Other descriptive name: VX-121
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: TEZACAFTOR
Product Name: VX-561
INN or Proposed INN: N/A
Other descriptive name: VX-561
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
108 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Netherlands;Germany;United Kingdom
83NCT03912233
(ClinicalTrials.gov)
April 30, 201910/4/2019A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic FibrosisCystic FibrosisDrug: VX-121;Drug: TEZ;Drug: VX-561;Drug: TEZ/IVA;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll87Phase 2United States;Germany;Netherlands;Portugal;United Kingdom
84NCT03911713
(ClinicalTrials.gov)
April 17, 20199/4/2019A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisCystic FibrosisDrug: VX-561;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll77Phase 2United States;Australia;Belgium;Germany;Ireland;Netherlands;United Kingdom
85EUCTR2018-002496-18-GB
(EUCTR)
08/03/201930/01/2019A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121
INN or Proposed INN: N/A
Other descriptive name: VX-121
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: TEZACAFTOR
Product Name: VX-561
INN or Proposed INN: N/A
Other descriptive name: VX-561
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
108Phase 2Portugal;United States;Netherlands;Germany;United Kingdom
86EUCTR2018-000185-11-AT
(EUCTR)
27/02/201919/10/2018A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Trikafta
Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
87NCT03783286
(ClinicalTrials.gov)
February 6, 201918/12/2018Ivacaftor Treatment in 4 Month to 2 Year Old CF SubjectsNutritional Impact of Ivacaftor Treatment in 4 Month to 2 Year Old Children With CF Gating MutationsCystic FibrosisDrug: IvacaftorChildren's Hospital of PhiladelphiaVertex Pharmaceuticals IncorporatedCompleted4 Months2 YearsAll15United States
88EUCTR2018-000185-11-GR
(EUCTR)
20/12/201828/11/2018A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Trikafta
Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
89NCT03624101
(ClinicalTrials.gov)
December 1, 20187/8/2018Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon MutationsNovel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon MutationsCystic FibrosisDrug: Trikafta;Drug: symdeko/Trikafta;Drug: Ivacaftor/TrikaftaUniversity of Alabama at BirminghamNULLCompleted18 YearsN/AAll1Phase 4United States
90EUCTR2018-000185-11-NL
(EUCTR)
14/11/201819/09/2018A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Trifakta
Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Sweden
91EUCTR2017-002968-40-PL
(EUCTR)
31/10/201829/06/2018A Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in subjects with cistic fibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation - Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
121Phase 3France;United States;Canada;Belgium;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
92EUCTR2018-000185-11-GB
(EUCTR)
19/10/201804/07/2018A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Trikafta
Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
93EUCTR2018-000185-11-CZ
(EUCTR)
15/10/201809/07/2018A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Trikafta
Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
94NCT03525574
(ClinicalTrials.gov)
October 9, 20182/5/2018A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del MutationCystic FibrosisDrug: VX-445;Drug: TEZ;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 YearsN/AAll507Phase 3United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Greece;Italy;Netherlands;Sweden;United Kingdom
95EUCTR2018-000185-11-IT
(EUCTR)
04/10/201822/01/2021A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation - NA Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Trikafta
Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC
Product Code: [ELX/TEZ/IVA]
INN or Proposed INN: Elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: [VX-770]
INN or Proposed INN: IVACAFTOR
VERTEX PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
96NCT03691779
(ClinicalTrials.gov)
October 2, 201828/9/2018Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of AgeA Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of AgeCystic FibrosisDrug: VX-445;Drug: TEZ;Drug: IVAVertex Pharmaceuticals IncorporatedNULLCompleted6 Years11 YearsAll66Phase 3United States;Australia;Ireland;United Kingdom
97EUCTR2018-000183-28-CZ
(EUCTR)
01/10/201809/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
98EUCTR2018-000183-28-GR
(EUCTR)
01/10/201825/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
99NCT03956589
(ClinicalTrials.gov)
October 1, 20182/5/2019Functional Respiratory Imaging and Orkambi in CFFunctional Respiratory Imaging (FRI) to Assess the Short-term Effect of the Product ORKAMBI (Lumacaftor/ Ivacaftor) on Lung Function in ORKAMBInaive Patients With Cystic Fibrosis Homozygous for Phe508delCystic FibrosisDrug: OrkambiUniversity Hospital, AntwerpNULLTerminated12 YearsN/AAll12Phase 4Belgium
100EUCTR2018-000184-89-GB
(EUCTR)
27/09/201804/07/2018A Phase 3 Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F).A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg VX-445/50mg TEZ /75mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: ivacaftor
Product Name: 100 mg TEZ/150 mg IVA FDC
Product Code: TEZ/IVA
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Belgium;Netherlands;United Kingdom
101EUCTR2018-000183-28-GB
(EUCTR)
27/09/201804/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
102EUCTR2016-004479-35-PL
(EUCTR)
26/09/201817/05/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation - A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic F Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Belgium;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
103EUCTR2017-004134-29-PL
(EUCTR)
24/09/201813/07/2018A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/ TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
104EUCTR2018-000183-28-DE
(EUCTR)
20/09/201803/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
105EUCTR2018-000183-28-IT
(EUCTR)
17/09/201809/02/2021A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) - NA Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: [VX-445/TEZ/IVA]
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: [VX-770]
INN or Proposed INN: Ivacaftor
VERTEX PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
106EUCTR2018-000184-89-NL
(EUCTR)
12/09/201816/08/2018A Phase 3 Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F).A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg VX-445/50mg TEZ /75mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: ivacaftor
Product Name: 100 mg TEZ/150 mg IVA FDC
Product Code: TEZ/IVA
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Belgium;Netherlands;United Kingdom
107EUCTR2018-000184-89-BE
(EUCTR)
07/09/201809/07/2018A Phase 3 Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F).A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg VX-445/50mg TEZ /75mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: ivacaftor
Product Name: 100 mg TEZ/150 mg IVA FDC
Product Code: TEZ/IVA
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Belgium;Netherlands;United Kingdom
108EUCTR2018-000185-11-BE
(EUCTR)
07/09/201817/07/2018A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Trikafta
Product Name: 100 mg ELX /50 mg TEZ /75 mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
109EUCTR2018-000183-28-BE
(EUCTR)
07/09/201809/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
110EUCTR2018-000183-28-NL
(EUCTR)
03/09/201818/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Sweden
111EUCTR2017-004134-29-DK
(EUCTR)
29/08/201803/07/2018A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/ TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Canada;Spain;Poland;Ireland;Australia;Denmark;Israel;Norway;Germany;United Kingdom;Switzerland
112EUCTR2018-000183-28-SE
(EUCTR)
27/08/201829/06/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
113EUCTR2018-000183-28-AT
(EUCTR)
24/08/201820/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
114NCT03601637
(ClinicalTrials.gov)
August 23, 201818/7/2018Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508delA Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508delCystic FibrosisDrug: LUM;Drug: IVAVertex Pharmaceuticals IncorporatedNULLCompleted12 Months23 MonthsAll60Phase 3United States;Canada
115EUCTR2017-004134-29-GB
(EUCTR)
22/08/201823/02/2018A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/ TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;Switzerland;United Kingdom
116NCT03625466
(ClinicalTrials.gov)
August 10, 20187/8/2018A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delAn Exploratory Phase 2, 2-part, Randomized, Double-blind, Placebo-controlled Study With a Long-term, Open-label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delCystic FibrosisDrug: LUM;Drug: IVA;Drug: Matched PlacebosVertex Pharmaceuticals IncorporatedNULLActive, not recruiting2 Years5 YearsAll51Phase 2Germany
117EUCTR2016-004479-35-FR
(EUCTR)
08/08/201804/06/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
118NCT03525548
(ClinicalTrials.gov)
August 3, 20182/5/2018A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)Cystic FibrosisDrug: VX-445/TEZ/IVA;Drug: TEZ/IVA;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll113Phase 3United States;Belgium;Netherlands;United Kingdom
119NCT03633526
(ClinicalTrials.gov)
August 3, 201827/7/2018Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of AgeA Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-659/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of AgeCystic FibrosisDrug: VX-659/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLTerminated6 Years11 YearsAll18Phase 3United States
120NCT03447262
(ClinicalTrials.gov)
July 13, 201821/2/2018A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination TherapyA Phase 3, Open-label Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del MutationCystic FibrosisDrug: VX-659;Drug: TEZ;Drug: IVAVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll484Phase 3United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom
121NCT04732910
(ClinicalTrials.gov)
July 1, 201825/1/2021Cystic Fibrosis Transmembrane Regulator (CFTR) Biomarker Study to Evaluate the Rescue of Mutant CFTR in Patients With Cystic Fibrosis Treated With CFTR-modulatorsCFTR Biomarker Studie Bei Patient*Innen Mit Mukoviszidose Und CFTR-ModulatortherapieCystic FibrosisDrug: Treatment with cystic fibrosis transmembrane regulator (CFTR) modualtors Ivacaftor, Lumacaftor-Ivacaftor, Tezacaftor-Ivacaftor, Elexacaftor-Tezacaftor-IvacaftorCharite University, Berlin, GermanyHannover Medical School;Heidelberg University;University of GiessenRecruiting6 MonthsN/AAll90Germany
122NCT03565692
(ClinicalTrials.gov)
July 1, 201831/5/2018Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-IvacaftorLum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-IvacaftorCystic FibrosisBiological: the lung mycobiota and microbiota profile;Biological: the gut mycobiota and microbiota profileUniversity Hospital, BordeauxSociete Francaise de la MucoviscidoseRecruiting2 YearsN/AAll250France
123EUCTR2017-002968-40-GB
(EUCTR)
28/06/201807/03/2018A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symkevi
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;Switzerland;United Kingdom
124EUCTR2017-002968-40-DK
(EUCTR)
28/06/201824/06/2018A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symkevi
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland
125EUCTR2017-003761-99-DE
(EUCTR)
27/06/201819/02/2018A Study of the Effects of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delAn Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor / ivacaftor
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor / ivacaftor
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Orkambi 100 mg/125 mg film-coated tablets
Product Name: LUM/IVA fixed-dose combination
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Germany
126EUCTR2016-004479-35-DE
(EUCTR)
26/06/201806/04/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
127EUCTR2017-002968-40-BE
(EUCTR)
26/06/201830/03/2018A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symkevi
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
128EUCTR2016-004479-35-BE
(EUCTR)
26/06/201830/03/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
129NCT03525444
(ClinicalTrials.gov)
June 15, 20182/5/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)Cystic FibrosisDrug: VX-445/TEZ/IVA;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll405Phase 3United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Greece;Italy;Netherlands;Sweden;United Kingdom
130EUCTR2018-001573-24-BE
(EUCTR)
11/06/201808/05/2018Evaluation of the short-term effect of ORKAMBI on lung function in patients with cystic fibrosis who have two copies of the F508del mutation using functional respiratory imagingFunctional Respiratory Imaging (FRI) to assess the short-term effect of the product ORKAMBI (lumacaftor/ ivacaftor) on lung function in ORKAMBI-naive patients with Cystic Fibrosis Homozygous for Phe508del. Cystic Fibrosis Homozygous (homozygous for the F508del mutation)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Orkambi
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Antwerp University HospitalNULLNot RecruitingFemale: yes
Male: yes
20Phase 4Belgium
131EUCTR2016-001440-18-NL
(EUCTR)
30/05/201816/01/2018The influence of cytochrome P450 3A4 inhibitors on serum levels of Ivacaftor in cystic fibrosis patients and healthy subjects.Pharmacokinetic interactions between ivacaftor and cytochrome P450 3A4 inhibitors in cystic fibrosis patients and healthy controls - IACI cystic fibrosis and healthy subjects;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Ivacaftor
Trade Name: claritromycin 500mg film coated tablets
Product Name: Claritromycin
Trade Name: Azithromycin 500 mg film-coated tablet
Product Name: azithromycin
Trade Name: Norvir 100 mg film-coated tablets
Product Name: Norvir
university medical center utrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 4Netherlands
132EUCTR2017-004132-11-ES
(EUCTR)
18/05/201805/03/2018A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
133EUCTR2017-004133-82-ES
(EUCTR)
18/05/201815/03/2018A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor/Ivacaftor/100mg/150mg
Product Code: VX-661/VX-770 (TEZ/IVA)
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United Kingdom;Germany;Australia;Ireland;Spain;United States
134EUCTR2017-004134-29-ES
(EUCTR)
18/05/201821/03/2018A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/ TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
460Phase 3United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
135NCT03559062
(ClinicalTrials.gov)
May 17, 20185/6/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic FibrosisDrug: TEZ/IVA;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted6 Years11 YearsAll67Phase 3Australia;Belgium;Denmark;France;Germany;Ireland;Poland;Switzerland;United Kingdom
136EUCTR2017-004134-29-IE
(EUCTR)
15/05/201805/03/2018A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/ TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
137EUCTR2017-004132-11-DK
(EUCTR)
08/05/201802/03/2018A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Poland;Spain;Ireland;Australia;Denmark;Israel;Norway;Germany;United Kingdom;Switzerland
138EUCTR2017-004132-11-GB
(EUCTR)
02/05/201823/02/2018A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;Switzerland;United Kingdom
139EUCTR2017-004133-82-GB
(EUCTR)
02/05/201814/06/2018A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor/Ivacaftor/100mg/150mg
Product Code: VX-661/VX-770 (TEZ/IVA)
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Australia;Germany;United Kingdom
140EUCTR2017-004133-82-IE
(EUCTR)
01/05/201805/03/2018A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor/Ivacaftor/100mg/150mg
Product Code: VX-661/VX-770 (TEZ/IVA)
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Spain;Ireland;Australia;Germany;United Kingdom
141NCT03460990
(ClinicalTrials.gov)
May 1, 20181/3/2018A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)Cystic FibrosisDrug: VX-659/TEZ/IVA;Drug: TEZ/IVA;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll116Phase 3United States;Australia;Germany;Ireland;Spain;United Kingdom
142EUCTR2017-004132-11-IE
(EUCTR)
01/05/201805/03/2018A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
143EUCTR2017-002968-40-IE
(EUCTR)
27/04/201808/03/2018A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symkevi
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
144NCT03537651
(ClinicalTrials.gov)
April 25, 201815/5/2018A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR MutationA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR MutationCystic FibrosisDrug: TEZ;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting6 YearsN/AAll130Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Poland;Switzerland;United Kingdom
145EUCTR2017-004132-11-DE
(EUCTR)
25/04/201827/02/2018A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Germany;United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;United Kingdom;Switzerland
146EUCTR2016-004479-35-GB
(EUCTR)
24/04/201826/04/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
65Phase 3France;Poland;Belgium;Ireland;Denmark;Australia;Germany;Switzerland;United Kingdom
147EUCTR2016-004479-35-DK
(EUCTR)
18/04/201822/02/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland
148NCT03768089
(ClinicalTrials.gov)
March 20, 20185/12/2018Study of VX-121 in Healthy Subjects and in Subjects With Cystic FibrosisA Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic FibrosisCystic FibrosisDrug: VX-121;Drug: TEZ/IVA;Drug: IVA;Drug: Matched PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll114Phase 1/Phase 2Netherlands;United Kingdom
149EUCTR2018-000126-55-NL
(EUCTR)
15/03/201815/05/2018A study to investigate the safety and the movement of the study drug VX-121 around the body in healthy people and patients with cystic fibrosisA Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121
INN or Proposed INN: Not yet assigned
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
120Phase 1;Phase 2Netherlands
150NCT03447249
(ClinicalTrials.gov)
March 7, 201821/2/2018A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)Cystic FibrosisDrug: VX-659/TEZ/IVA;Drug: IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll385Phase 3United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom
151NCT02653027
(ClinicalTrials.gov)
January 1, 20187/1/2016Effect of Lumacaftor-ivacaftor on Glucose Handling and Tolerance in Cystic Fibrosis Phe508delA Study of the Effect of Combination Lumacaftor and Ivacaftor on Glucose Tolerance in Persons With Cystic Fibrosis Who Are Homozygous for the Phe508del Cystic Fibrosis Transmembrane Conductance Regulator Mutation.Diabetes;Cystic FibrosisDrug: Lumacaftor-ivacaftor;Other: OGTTMassachusetts General HospitalNULLWithdrawn18 Years65 YearsAll0N/ANULL
152EUCTR2017-000540-18-DE
(EUCTR)
08/11/201713/09/2017Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Subjects With Cystic Fibrosis (CF) Who Have Previously Discontinued Orkambi Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Germany
153EUCTR2017-000797-11-NL
(EUCTR)
06/10/201730/05/2017A Study of VX-445 in Healthy Subjects and Subjects with Cystic FibrosisA Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;Belgium;Australia;Netherlands
154EUCTR2017-000797-11-BE
(EUCTR)
28/08/201715/06/2017A Study of VX-445 in Healthy Subjects and Subjects with Cystic FibrosisA Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Product Name: Deuterated Ivacaftor
Product Code: VX-561 (CTP-656)
INN or Proposed INN: VX-561
Other descriptive name: VX-561
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
104Phase 2United States;Belgium;Australia;Netherlands
155NCT03278314
(ClinicalTrials.gov)
August 27, 20176/9/2017Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic FibrosisTezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic FibrosisCystic FibrosisDrug: tezacaftor/ivacaftorVertex Pharmaceuticals IncorporatedNULLApproved for marketing12 YearsN/AAllNULL
156EUCTR2015-001997-16-IE
(EUCTR)
17/08/201711/04/2017A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Ivacaftor-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
35Phase 3United States;Canada;Ireland;Germany;United Kingdom
157NCT03277196
(ClinicalTrials.gov)
August 16, 20176/9/2017A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive MutationA Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive MutationCystic FibrosisDrug: IvacaftorVertex Pharmaceuticals IncorporatedNULLEnrolling by invitationN/A24 MonthsAll75Phase 3United States;Australia;Canada;Germany;Ireland;United Kingdom
158EUCTR2016-003585-11-GB
(EUCTR)
10/08/201710/07/2017Study to Evaluate the Safety and Efficacy of VX-659 drug in combination with other drugs in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659
Product Code: VX-659
INN or Proposed INN: VX-659
Other descriptive name: VX-659
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor/Ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: TEZACAFTOR
Product Name: Deuterated Ivacaftor
Product Code: VX-561 (CTP-656)
INN or Proposed INN: Deuterated Ivacaftor
Other descriptive name: VX-561 (CTP-656)
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
105Phase 2United States;Ireland;Israel;United Kingdom
159NCT03224351
(ClinicalTrials.gov)
August 8, 201718/7/2017A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic FibrosisCystic FibrosisDrug: TEZ/IVA;Drug: VX-659;Drug: IVA;Drug: Matched Placebos;Drug: TEZ;Drug: VX-561Vertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll124Phase 2United States;Ireland;Israel;United Kingdom
160EUCTR2017-001379-21-GB
(EUCTR)
01/08/201720/07/2017A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
75Phase 3United Kingdom;Germany;Ireland;Canada;United States
161NCT03068312
(ClinicalTrials.gov)
July 18, 201724/2/2017A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C?T or D1152H CFTR MutationA Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older and Have Either a 3849 + 10KB C?T or D1152H-CFTR MutationCystic FibrosisDrug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted6 YearsN/AAll38Phase 3Israel
162NCT03150719
(ClinicalTrials.gov)
May 24, 20173/5/2017A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF)Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del CFTR MutationCystic FibrosisDrug: Tezacaftor/Ivacaftor;Drug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll98Phase 3United States;France;Germany
163NCT03125395
(ClinicalTrials.gov)
May 12, 201719/4/2017A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationA Phase 3, Rollover Study to Evaluate the Safety of Long-term Treatment With Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: LUM/IVAVertex Pharmaceuticals IncorporatedNULLCompleted2 YearsN/AAll57Phase 3United States;Canada
164EUCTR2016-000454-36-NL
(EUCTR)
05/05/201702/11/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
165EUCTR2016-004996-33-ES
(EUCTR)
03/05/201710/03/2017A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del-CFTR MutationA Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallelgroup, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del-CFTR Mutation Cystic fibrosis subjects Homozygous for the F508del-CFTR Mutation
MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Orkambi
Product Name: Orkambi
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVACAFTOR
Vertex Pharmaceuticals IncoporatedNULLNot RecruitingFemale: yes
Male: yes
75Phase 4United States;Canada;Spain;Australia;United Kingdom
166NCT03256799
(ClinicalTrials.gov)
March 17, 201718/8/2017Evaluation of Ivacaftor in Patients Using Ataluren for Nonsense MutationsAn Open Label Study to Investigate the Role of Ivacaftor for the Treatment of Cystic Fibrosis in Combination With Ataluren (PTC124) in Cystic Fibrosis Patients Using Ataluren for Nonsense MutationsCystic FibrosisDrug: Ivacaftor/AtalurenUniversity of Alabama at BirminghamNULLCompleted19 YearsN/AAll1Phase 4United States
167NCT03061331
(ClinicalTrials.gov)
January 31, 20179/2/2017Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR MutationCystic FibrosisDrug: LUM/IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll20Phase 2Netherlands
168NCT03256968
(ClinicalTrials.gov)
January 27, 201718/8/2017PTC Study to Evaluate Ataluren in Combination With IvacaftorAn Open Label N of 1 Study to Evaluate the Study and Efficacy of Long-Term Treatment With Ivacaftor in Combination With Ataluren (PTC124) in Subjects With Nonsense Mutation Cystic FibrosisCystic FibrosisDrug: AtalurenUniversity of Alabama at BirminghamNULLCompleted6 YearsN/AAll1Phase 4United States
169EUCTR2016-000454-36-BE
(EUCTR)
24/01/201725/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Spain;Belgium;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
170NCT03227471
(ClinicalTrials.gov)
January 23, 201718/7/2017A Study of VX-445 in Healthy Subjects and Subjects With Cystic FibrosisA Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic FibrosisCystic FibrosisDrug: IVA;Drug: TEZ/IVA;Drug: VX-445;Drug: Matched Placebo;Drug: TEZ;Drug: VX-561Vertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll230Phase 1/Phase 2United States;Australia;Belgium;Netherlands
171EUCTR2016-000454-36-ES
(EUCTR)
18/01/201726/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
172EUCTR2016-000454-36-IT
(EUCTR)
16/01/201727/02/2018A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVACAFTOR
VERTEX PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
173EUCTR2016-000454-36-GB
(EUCTR)
10/01/201707/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
198 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
174EUCTR2016-002837-31-CZ
(EUCTR)
04/01/201724/10/2016A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
175EUCTR2016-000454-36-DE
(EUCTR)
04/01/201712/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
176EUCTR2015-004841-13-CZ
(EUCTR)
04/01/201710/08/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Ivacaftor
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic saline
INN or Proposed INN: 4.2% NaCl/inhalation solution
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Czech Republic;Ireland;United Kingdom
177EUCTR2016-000454-36-AT
(EUCTR)
03/01/201707/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Australia;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
178NCT03045523
(ClinicalTrials.gov)
January 201726/1/2017A Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic FibrosisA Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis Harbouring One F508del CFTR Mutation and a Second Gating (Class III) MutationCystic FibrosisDrug: GLPG2222 150 mg q.d.;Drug: GLPG2222 300 mg q.d.;Drug: PlaceboGalapagos NVNULLCompleted18 Years99 YearsAll37Phase 2Australia;Belgium;Czechia;Germany;Ireland;United Kingdom
179EUCTR2016-002837-31-DE
(EUCTR)
29/12/201624/10/2016A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation - Albatross Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
180NCT04623879
(ClinicalTrials.gov)
December 29, 201612/10/2020Real Life Evaluation of the Multi-organ Effects of Lumacaftor/Ivacaftor on F508del Homozygous Cystic Fibrosis Patients.Real Life Evaluation of the Multi-organ Effects of Lumacaftor/Ivacaftor on F508del Homozygous Cystic Fibrosis Patients.Cystic FibrosisDrug: Lumacaftor, Ivacaftor Drug CombinationCarmel Medical CenterNULLCompleted18 Years99 YearsAll13NULL
181EUCTR2016-001585-29-NL
(EUCTR)
21/12/201618/07/2016Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Orkambi 200 mg/125 mg film-coated tablets
Product Name: LUM/IVA fixed-dose combination
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Netherlands
182EUCTR2016-002837-31-BE
(EUCTR)
16/12/201624/10/2016A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
183EUCTR2016-002837-31-GB
(EUCTR)
05/12/201617/10/2016A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
184EUCTR2016-002837-31-IE
(EUCTR)
02/12/201604/10/2016A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
185NCT02971839
(ClinicalTrials.gov)
December 201621/11/2016Study to Evaluate the Safety and Efficacy of CTP-656 in Patients With Cystic Fibrosis With CFTR Gating MutationsA Phase 2, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of CTP-656 With an Open-Label Active Comparator in Patients With Cystic Fibrosis With CFTR Gating Mutations.Cystic FibrosisDrug: VX-561;Drug: Placebo;Drug: IVAVertex Pharmaceuticals IncorporatedNULLTerminated18 YearsN/AAll11Phase 2United States
186EUCTR2016-000454-36-DK
(EUCTR)
18/11/201610/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Austria;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
187NCT02934698
(ClinicalTrials.gov)
November 1, 201613/10/2016An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing MutationsAn Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing MutationsCystic FibrosisDrug: IvacaftorMedical University of South CarolinaVertex Pharmaceuticals IncorporatedCompleted18 YearsN/AFemale2Phase 3NULL
188NCT02953314
(ClinicalTrials.gov)
November 201618/10/2016A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)A Phase 3, Open Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR MutationCystic FibrosisDrug: TEZ;Drug: TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLCompleted6 Years11 YearsAll83Phase 3United States;Canada
189NCT02951195
(ClinicalTrials.gov)
November 201626/10/2016A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic FibrosisA Phase 2, Randomized, Double Blind, Controlled Study to Evaluate the Safety of VX-152 Combination Therapy in Adults With Cystic FibrosisCystic FibrosisDrug: VX-152;Drug: Tezacaftor;Drug: Ivacaftor;Drug: Triple Placebo;Drug: Placebo for VX-152Vertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll80Phase 2United States
190NCT03029455
(ClinicalTrials.gov)
November 201611/1/2017A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic FibrosisA Phase 1, Randomized, Double Blind, Placebo Controlled, Dose Escalation, and Bioavailability Study Evaluating the Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Subjects With Cystic FibrosisCystic FibrosisDrug: VX-659;Drug: Tezacaftor;Drug: Ivacaftor;Drug: VX-659 Matching Placebo;Drug: Triple Combination (TC) Matching PlacebosVertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll163Phase 1United Kingdom
191NCT02951182
(ClinicalTrials.gov)
October 201626/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic FibrosisCystic FibrosisDrug: TEZ;Drug: IVA;Drug: VX-440;Drug: Matched PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll74Phase 2United States;Australia;Austria;Belgium;Canada;Denmark;Germany;Italy;Spain;United Kingdom
192NCT02730208
(ClinicalTrials.gov)
September 201631/3/2016A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR MutationA Phase 2, Randomized, Placebo-Controlled, Double-blind Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic FibrosisDrug: Tezacaftor/Ivacaftor;Drug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll41Phase 2Australia
193NCT02875366
(ClinicalTrials.gov)
September 201615/8/2016A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR MutationA Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: LUM/IVA;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll70Phase 4Australia;United Kingdom
194EUCTR2014-004838-25-DE
(EUCTR)
16/08/201617/05/2016A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
155Phase 3United States;France;Canada;Belgium;Ireland;Austria;Germany;United Kingdom;Italy
195EUCTR2016-001785-29-IE
(EUCTR)
15/08/201610/05/2016Study of the effects of combined treatment with the CFTR corrector ivacaftor and IV antibiotics on infection in CF.Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Kalydeco
INN or Proposed INN: IVACAFTOR
Trade Name: Ciprofloxacin
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
Product Name: Flucloxicillin
INN or Proposed INN: FLUCLOXACILLIN SODIUM
Trade Name: Fortum
INN or Proposed INN: CEFTAZIDIME
Product Name: Tobramycin
INN or Proposed INN: TOBRAMYCIN SULFATE
Trade Name: Meropenem
INN or Proposed INN: Meropenem
Other descriptive name: MEROPENEM
Trade Name: Colistin
INN or Proposed INN: COLISTIMETHATE SODIUM
St. Vincent's University HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 4Ireland
196EUCTR2015-004841-13-IE
(EUCTR)
08/08/201607/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic Saline
INN or Proposed INN: 4.2% NaCl/Inhalation solution
Vertex Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Czech Republic;Ireland;United Kingdom
197NCT02858843
(ClinicalTrials.gov)
August 1, 20165/7/2016The Effect of Combination Lumacaftor and Ivacaftor on Markers of HyperglycemiaA Study of the Effect of Combination Lumacaftor and Ivacaftor on Markers of Hyperglycemia in Persons With Cystic FibrosisCystic Fibrosis;DiabetesDrug: lumacaftor-ivacaftorMassachusetts General HospitalNULLTerminated18 Years65 YearsAll1N/ANULL
198EUCTR2015-004841-13-GB
(EUCTR)
20/07/201609/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic saline
INN or Proposed INN: 4.2% NaCl/Inhalation solution
Vertex Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Ireland;United Kingdom
199NCT03486236
(ClinicalTrials.gov)
July 20, 201627/3/2018A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult SubjectsA Phase 1, Randomized, Double Blind, Placebo Controlled, Multiple Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With VX-661/Ivacaftor in Healthy Adult SubjectsCystic FibrosisDrug: VX-440;Drug: TEZ;Drug: IVA;Drug: Matched PlacebosVertex Pharmaceuticals IncorporatedNULLCompleted18 Years55 YearsAll16Phase 1United Kingdom
200EUCTR2016-000066-34-GB
(EUCTR)
24/06/201625/07/2017A Study of the Effects of Lumacaftor/Ivacaftor on Exercise Tolerance in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationA Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation. Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: lumacaftor
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesAustralia;United Kingdom
201EUCTR2015-001267-39-GB
(EUCTR)
20/06/201624/08/2015A study to assess the efficacy and safety of ivacaftor in children aged 3 to 5 with Cystic Fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3b, 2-part, Randomized, Double-blind, Placebo-controlled Crossover Study With a Long term Open-label Period to Investigate Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Canada;Australia;United Kingdom
202EUCTR2014-004788-18-BE
(EUCTR)
03/06/201603/03/2016A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland
203EUCTR2014-004838-25-AT
(EUCTR)
02/06/201620/04/2016A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
155Phase 3France;United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
204NCT02807415
(ClinicalTrials.gov)
June 1, 201616/6/2016ICM to Evaluate the Activation of p.Phe508del-CFTR by Lumacaftor in Combination With IvacaftorIntestinal Current Measurements (ICM) to Evaluate the Activation of Mutant CFTR in Subjects With Cystic Fibrosis Aged 12 Years and Older, Homozygous for the p.Phe508del-CFTR Mutation, Treated With Lumacaftor in Combination With IvacaftorCystic FibrosisDrug: Lumacaftor plus IvacaftorHannover Medical SchoolHeidelberg University;University of GiessenCompleted6 YearsN/AAll104Germany
205NCT02823470
(ClinicalTrials.gov)
June 20161/7/2016A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR MutationA Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallel-group, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del CFTR MutationCystic FibrosisDrug: LUM/IVA;Device: activated smart device;Device: de-activated smart deviceVertex Pharmaceuticals IncorporatedNULLTerminated16 YearsN/AAll24Phase 4United States;Canada
206EUCTR2015-001644-11-DE
(EUCTR)
25/05/201631/03/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
207NCT02797132
(ClinicalTrials.gov)
May 201625/5/2016Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delA Phase 3, 2-Part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: LUM/IVAVertex Pharmaceuticals IncorporatedNULLCompleted2 Years5 YearsAll62Phase 3United States;Canada
208NCT02742519
(ClinicalTrials.gov)
May 201614/4/2016A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating MutationA Phase 3b, 2-part, Randomized, Double-blind, Placebo-controlled Crossover Study With a Long-term Open-label Period to Investigate Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating MutationCystic FibrosisDrug: ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLTerminated3 Years5 YearsAll14Phase 3Australia;Canada;United Kingdom
209EUCTR2015-001644-11-BE
(EUCTR)
06/04/201608/01/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
210NCT02724527
(ClinicalTrials.gov)
April 201611/3/2016Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With IvacaftorA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 for Efficacy and Safety in Patients With CF Heterozygous for F508del-CFTR + Gating Mutation Being Treated With IvacaftorCystic FibrosisDrug: Cavosonstat;Drug: PlaceboNivalis Therapeutics, Inc.NULLActive, not recruiting18 YearsN/ABoth19Phase 2United States
211EUCTR2015-001644-11-FR
(EUCTR)
16/03/201620/04/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
212EUCTR2015-001644-11-DK
(EUCTR)
15/03/201608/02/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Sweden
213NCT02725567
(ClinicalTrials.gov)
March 201614/3/2016A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR MutationA Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR MutationCystic FibrosisDrug: ivacaftorVertex Pharmaceuticals IncorporatedNULLActive, not recruitingN/A24 MonthsAll56Phase 3United States;Australia;Canada;Ireland;United Kingdom
214EUCTR2014-004827-29-DE
(EUCTR)
24/02/201621/09/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
215NCT03512119
(ClinicalTrials.gov)
February 11, 201615/1/2018Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-IvacaftorObservational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-IvacaftorCystic Fibrosis Homozygous for Phe 508 Del CFTR;Glucose Intolerance or Newly Diagnosis DiabetesDrug: Lumacaftor-Ivacaftor treatmentUniversity Hospital, Strasbourg, FranceNULLCompleted12 YearsN/AAll55France
216NCT02508207
(ClinicalTrials.gov)
February 201623/7/2015A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Exploratory Study to Evaluate Effects of VX-661 in Combination With Ivacaftor on Lung and Extrapulmonary Systems in Subjects Aged 18 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: Tezacaftor/Ivacaftor;Drug: Ivacaftor;Drug: Tezacaftor/Ivacaftor matching placebo;Drug: Ivacaftor matching placeboVertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll34Phase 2United States
217NCT03475381
(ClinicalTrials.gov)
January 22, 20164/1/2018Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*)Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*)Cystic FibrosisDrug: Ivacaftor+lumacaftorAssistance Publique - Hôpitaux de ParisEffi-Stat;Societe Francaise de la MucoviscidoseCompleted12 YearsN/AAll852France
218EUCTR2015-001644-11-GB
(EUCTR)
22/01/201610/11/2015Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
219EUCTR2014-004827-29-ES
(EUCTR)
12/01/201618/11/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
220EUCTR2014-004837-13-DE
(EUCTR)
15/12/201521/04/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
221EUCTR2014-004827-29-SE
(EUCTR)
09/12/201527/08/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
222EUCTR2014-004827-29-DK
(EUCTR)
30/11/201511/09/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
223EUCTR2014-004827-29-AT
(EUCTR)
27/11/201527/08/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
224EUCTR2014-004827-29-GB
(EUCTR)
03/11/201505/08/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Symkevi
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
225EUCTR2014-004827-29-NL
(EUCTR)
03/11/201521/09/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
226NCT02589236
(ClinicalTrials.gov)
November 201526/10/2015Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 to Evaluate Efficacy and Safety in Patients With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation Treated With Lumacaftor/IvacaftorCystic FibrosisDrug: Cavosonstat;Drug: PlaceboNivalis Therapeutics, Inc.Medidata SolutionsCompleted18 YearsN/AAll138Phase 2United States
227EUCTR2014-004787-37-ES
(EUCTR)
26/10/201525/08/2015A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs.A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Spain;Austria;Australia;Israel;Germany
228EUCTR2014-004827-29-BE
(EUCTR)
21/10/201506/08/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
229EUCTR2014-004827-29-IE
(EUCTR)
19/10/201509/07/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
230EUCTR2015-000543-16-DE
(EUCTR)
14/10/201518/05/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
231EUCTR2015-000543-16-BE
(EUCTR)
24/09/201508/06/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
232EUCTR2014-004787-37-DE
(EUCTR)
24/09/201519/06/2015A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs.A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Spain;Austria;Australia;Israel;Germany
233EUCTR2015-000543-16-DK
(EUCTR)
23/09/201522/05/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Sweden
234EUCTR2014-004787-37-AT
(EUCTR)
21/09/201518/06/2015A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs.A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Spain;Australia;Austria;Israel;Germany
235EUCTR2014-004827-29-IT
(EUCTR)
01/09/201508/07/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
236EUCTR2015-000543-16-SE
(EUCTR)
19/08/201520/05/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
237NCT02516410
(ClinicalTrials.gov)
August 201528/7/2015A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR MutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR)Cystic FibrosisDrug: VX-661 plus ivacaftor combination;Drug: Ivacaftor;Drug: Placebo (matched to VX-661 plus ivacaftor combination);Drug: Placebo (matched to ivacaftor)Vertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll168Phase 3United States;Australia;Austria;Canada;France;Israel;Spain
238NCT02544451
(ClinicalTrials.gov)
August 20151/9/2015Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With IvacaftorA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: LUM/IVAVertex Pharmaceuticals IncorporatedNULLCompleted6 YearsN/AAll246Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Sweden;United Kingdom
239NCT02565914
(ClinicalTrials.gov)
August 201518/9/2015A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis Who Have an F508del-CFTR MutationA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic FibrosisDrug: TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 YearsN/AAll1044Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom
240EUCTR2014-004838-25-BE
(EUCTR)
31/07/201526/05/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
241NCT02310789
(ClinicalTrials.gov)
July 31, 20153/9/2014(Study: Vertex IIS) Does Ivacaftor Alter Wild Type CFTR-Open Probability In The Sweat Gland Secretory Coil?(Study: Vertex IIS) A Study To Access the Effects of Ivacaftor on Wild Type CFTR-Open Probability (PO) In The Sweat Gland Secretory CoilCystic FibrosisDrug: Ivacaftor;Drug: ß-Adrenergic cocktail;Drug: Pilocarpine Nitrate 5%;Device: Macroduct sweat stimulatorRichard Barry MossNULLCompleted18 YearsN/AAll8N/AUnited States
242EUCTR2014-004788-18-DE
(EUCTR)
24/07/201531/03/2015A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland
243EUCTR2014-004837-13-IT
(EUCTR)
22/07/201527/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
244EUCTR2014-004788-18-IT
(EUCTR)
15/07/201519/03/2015A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy
245EUCTR2014-004837-13-NL
(EUCTR)
10/07/201508/04/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Germany;Netherlands;Italy;United Kingdom;Switzerland;Sweden
246EUCTR2014-004788-18-NL
(EUCTR)
10/07/201508/04/2015A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3France;United States;Canada;Belgium;Australia;Israel;Germany;Netherlands;Italy;United Kingdom
247EUCTR2014-004837-13-ES
(EUCTR)
02/07/201515/06/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3United States;France;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
248NCT02514473
(ClinicalTrials.gov)
July 201523/7/2015A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR MutationA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: VX-809;Drug: Placebo;Drug: VX-770Vertex Pharmaceuticals IncorporatedNULLCompleted6 Years11 YearsAll206Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Sweden;United Kingdom
249EUCTR2014-004837-13-DK
(EUCTR)
24/06/201526/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
250EUCTR2014-004838-25-IE
(EUCTR)
22/06/201510/04/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
155Phase 3France;United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
251EUCTR2015-000543-16-GB
(EUCTR)
19/06/201515/05/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
252EUCTR2014-004837-13-IE
(EUCTR)
11/06/201505/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
253EUCTR2014-004788-18-GB
(EUCTR)
08/06/201508/04/2015A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
204 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;Switzerland;United Kingdom
254NCT02412111
(ClinicalTrials.gov)
June 20153/4/2015A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to IvacaftorA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor ResponsiveCystic FibrosisDrug: Ivacaftor;Drug: Tezacaftor/IvacaftorVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll156Phase 3United States;Australia;Austria;Belgium;Canada;France;Germany;Ireland;Italy;United Kingdom
255EUCTR2014-004838-25-IT
(EUCTR)
20/05/201530/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Ireland;Austria;Germany;United Kingdom;Italy
256EUCTR2014-004837-13-GB
(EUCTR)
12/05/201520/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
490 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden
257EUCTR2014-004837-13-SE
(EUCTR)
24/04/201506/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3United States;France;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
258NCT02445053
(ClinicalTrials.gov)
April 201511/5/2015Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study)Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study)Cystic FibrosisDrug: ivacaftorVertex Pharmaceuticals IncorporatedNULLCompleted6 YearsN/AAll75Italy;Netherlands;United Kingdom
259NCT02392234
(ClinicalTrials.gov)
March 201512/3/2015A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) MutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual FunctionCystic FibrosisDrug: VX-661/Ivacaftor;Drug: Ivacaftor;Drug: Placebo matched to VX-661/ ivacaftor;Drug: Placebo matched to IvacaftorVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll248Phase 3United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Switzerland;United Kingdom
260NCT02390219
(ClinicalTrials.gov)
March 201511/3/2015Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung DiseaseA Phase 3b, Open-Label Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Cystic Fibrosis and Advanced Lung Disease, Homozygous for the F508del-CFTR MutationCystic Fibrosis;Advanced Lung DiseaseDrug: Lumacaftor;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll46Phase 3United States
261NCT02347657
(ClinicalTrials.gov)
January 201512/1/2015A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With IvacaftorA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic FibrosisDrug: VX-661 Plus Ivacaftor Combination;Drug: Ivacaftor;Drug: VX-661 Plus Ivacaftor Combination Placebo;Drug: Ivacaftor placeboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll510Phase 3United States;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom
262NCT02194881
(ClinicalTrials.gov)
October 201417/7/2014Ivacaftor in French Patients With Cystic Fibrosis and a G551D MutationIvacaftor in French Patients With Cystic Fibrosis and a G551D Mutation - Efficacy and Safety Results After the First Year of Treatment in the Real Life Setting.Cystic FibrosisDrug: CF patients with a G551D mutation and treated with IvacaftorAssistance Publique - Hôpitaux de ParisVaincre la MucoviscidoseCompleted6 YearsN/AAll57N/AFrance
263EUCTR2014-000817-30-NL
(EUCTR)
14/08/201422/05/2014Comparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutationComparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutation - TICTAC-study Cystic Fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Ivacaftor/Kalydeco
Product Name: Curcuma Longa Extract cpl formaat 00 23,2 x 8,5 mm 723 mg
INN or Proposed INN: curcumin
Other descriptive name: CURCUMIN
Product Name: Genisteine Plus 150 mg cpl formaat 1 18,7 x 6,4 mm 438 mg
INN or Proposed INN: genistein
Other descriptive name: GENISTEIN
University Medical Centre UtrechtNULLNot RecruitingFemale: yes
Male: yes
Phase 2Netherlands
264EUCTR2013-000604-41-DE
(EUCTR)
10/03/201420/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
265NCT02070744
(ClinicalTrials.gov)
March 201421/2/2014Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label ExpansionA Phase 2, Randomized, Multicenter, Double Blind, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 in Combination With Ivacaftor for 12 Weeks in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation With an Open-Label ExtensionCystic FibrosisDrug: VX-661;Drug: Ivacaftor;Drug: Placebo matched to VX-661;Drug: Placebo matched to IvacaftorVertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll40Phase 2United States
266EUCTR2013-000604-41-NL
(EUCTR)
14/02/201426/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
267NCT01937325
(ClinicalTrials.gov)
February 20144/9/2013CPET in CF Patients With One G551D Mutation Taking VX770Airway Infection, Inflammatory Markers and Exercise Capacity in Patients With Cystic Fibrosis and at Least One G551D Mutation Taking VX770 (Ivacaftor)Cystic FibrosisDrug: ivacaftor;Drug: placeboThe AlfredNULLActive, not recruiting16 Years70 YearsBoth20Phase 4Australia
268EUCTR2013-000604-41-IT
(EUCTR)
21/01/201414/08/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
269EUCTR2010-020413-90-IE
(EUCTR)
08/01/201413/12/2013Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Belgium;Ireland;Australia;Germany;United Kingdom
270EUCTR2010-020413-90-GB
(EUCTR)
06/01/201410/12/2013Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Belgium;Ireland;Australia;Germany;United Kingdom
271NCT02015507
(ClinicalTrials.gov)
January 20149/12/2013An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on Ivacaftor and VX-661 in Combination With IvacaftorAn Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on the Multiple-Dose Pharmacokinetics of Ivacaftor and on the Multiple-Dose Pharmacokinetics of VX-661 Administered in Combination With IvacaftorCystic FibrosisDrug: ivacaftor;Drug: VX-661;Drug: ciprofloxacinVertex Pharmaceuticals IncorporatedNULLCompleted18 Years55 YearsBoth34Phase 1NULL
272EUCTR2013-000604-41-CZ
(EUCTR)
18/12/201313/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
273EUCTR2013-000604-41-SE
(EUCTR)
10/12/201313/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
274EUCTR2013-000604-41-IE
(EUCTR)
09/12/201310/10/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
275EUCTR2013-000604-41-BE
(EUCTR)
04/12/201317/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
276EUCTR2013-000604-41-ES
(EUCTR)
03/12/201308/10/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
277NCT01946412
(ClinicalTrials.gov)
December 201316/9/2013Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating MutationA Phase 3, 2-Arm, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating MutationCystic FibrosisDrug: IvacaftorVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted2 YearsN/AAll33Phase 3United States;Canada;United Kingdom
278EUCTR2013-000604-41-DK
(EUCTR)
19/11/201319/11/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
279EUCTR2013-000604-41-AT
(EUCTR)
23/10/201316/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
280EUCTR2013-000604-41-GB
(EUCTR)
10/10/201317/09/2013A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
281NCT01931839
(ClinicalTrials.gov)
October 201326/8/2013A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic FibrosisA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationDrug: Lumacaftor Plus Ivacaftor Combination;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll1164Phase 3United States;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom
282NCT01784419
(ClinicalTrials.gov)
October 20133/2/2013Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis PatientsShort Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis PatientsCystic FibrosisDrug: ivacaftor;Drug: PlaceboUniversity of California, San FranciscoNULLCompleted6 YearsN/AAll10N/AUnited States
283EUCTR2012-003990-24-AT
(EUCTR)
26/08/201303/04/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Denmark;Australia;Austria;Germany;United Kingdom
284EUCTR2012-003989-40-NL
(EUCTR)
21/08/201317/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
285EUCTR2012-003990-24-ES
(EUCTR)
09/08/201316/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
501Phase 3France;United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom
286EUCTR2012-000386-20-GB
(EUCTR)
31/07/201326/04/2013A Roll-over study in children with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term safety and pharmacodynamics of ivacaftorA Phase 3, 2-Arm, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating Mutation cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;United Kingdom
287NCT01899105
(ClinicalTrials.gov)
July 201310/7/2013A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With IvacaftorA Phase 1, Randomized, Single-Dose, Open-Label Crossover Study to Investigate the Effect of Food on the Relative Bioavailability of 2 Fixed-Dose Combinations of Lumacaftor and Ivacaftor Tablet Formulations in Healthy Adult SubjectsCystic FibrosisDrug: lumacaftor;Drug: ivacaftorVertex Pharmaceuticals IncorporatedNULLCompleted18 Years55 YearsBoth28Phase 1United States
288NCT01897233
(ClinicalTrials.gov)
July 20138/7/2013Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationA Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: Lumacaftor;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNULLCompleted6 Years11 YearsAll62Phase 3United States;Canada
289EUCTR2012-000204-15-GB
(EUCTR)
28/06/201326/04/2013A study in children aged 2 to 5 with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the safety, pharmacokinetics and pharmacodynamics of ivacaftorA Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who are 2 Through 5 Years of Age and Have a CFTR Gating Mutation cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;United Kingdom
290EUCTR2012-003990-24-DK
(EUCTR)
27/06/201317/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Austria;Australia;Denmark;Germany;United Kingdom
291EUCTR2012-003989-40-CZ
(EUCTR)
26/06/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden
292EUCTR2012-003990-24-BE
(EUCTR)
25/06/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom
293EUCTR2012-003990-24-DE
(EUCTR)
20/06/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom
294EUCTR2012-003990-24-GB
(EUCTR)
10/06/201313/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
501 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom
295EUCTR2012-003989-40-GB
(EUCTR)
10/06/201313/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
501 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
296EUCTR2012-003989-40-IE
(EUCTR)
07/06/201311/04/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
297NCT01910415
(ClinicalTrials.gov)
June 201319/7/2013Phase 1, QT/QTC Interval Study in Healthy SubjectsA Phase 1, Randomized, Placebo and Active Controlled, Double-Blind, Parallel, Electrocardiogram Study to Evaluate the Effect of Lumacaftor in Combination With Ivacaftor on the QT/QTc Interval in Healthy SubjectsCystic FibrosisDrug: Lumacaftor;Drug: Lumacaftor Placebo;Drug: Ivacaftor;Drug: Ivacaftor Placebo;Drug: moxifloxacin hydrochlorideVertex Pharmaceuticals IncorporatedNULLCompleted18 Years55 YearsBoth200Phase 1Netherlands
298EUCTR2012-003989-40-IT
(EUCTR)
22/05/201321/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
299EUCTR2012-003989-40-DE
(EUCTR)
17/05/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
300EUCTR2012-003989-40-SE
(EUCTR)
07/05/201318/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden
301NCT01863238
(ClinicalTrials.gov)
May 201322/5/2013An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic FibrosisAn Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic FibrosisCystic FibrosisOther: Ophthalmologic examinations;Drug: Ivacaftor ExposedVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted6 Years11 YearsBoth95N/AUnited States
302NCT01807923
(ClinicalTrials.gov)
May 20134/3/2013A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR MutationA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic Fibrosis, Homozygous for the F508del CFTR MutationDrug: Lumacaftor Plus Ivacaftor Combination;Drug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll559Phase 3United States;Australia;Canada;Czech Republic;France;Germany;Ireland;Italy;Netherlands;Sweden;United Kingdom
303NCT01807949
(ClinicalTrials.gov)
April 20134/3/2013A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR MutationA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR MutationCystic Fibrosis, Homozygous for the F508del CFTR MutationDrug: Placebo;Drug: Lumacaftor Plus Ivacaftor Combination;Drug: IvacaftorVertex Pharmaceuticals IncorporatedNULLCompleted12 Years65 YearsAll563Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Spain;United Kingdom
304EUCTR2011-003821-93-DE
(EUCTR)
13/03/201323/12/2011A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR MutationA Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-661
Product Code: VX-661, VRT-893661
INN or Proposed INN: Not yet assigned
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Product Name: VX-661
Product Code: VX-661, VRT-893661
INN or Proposed INN: Not yet assigned
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
220Phase 2United States;Canada;Germany;United Kingdom
305NCT01707290
(ClinicalTrials.gov)
February 20139/10/2012Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR MutationA Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long Term Ivacaftor Treatment in Subjects 6 Years of Age and Older With Cystic Fibrosis and a Non-G551D CFTR MutationCystic FibrosisDrug: IvacaftorVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted6 YearsN/AAll125Phase 3United States;Belgium;France;United Kingdom;Ireland
306NCT01705145
(ClinicalTrials.gov)
January 20138/10/2012Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating MutationA Phase 3, 2-Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are 2 Through 5 Years of Age and Have a CFTR Gating MutationCystic FibrosisDrug: IvacaftorVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted2 Years5 YearsAll35Phase 3United States;Canada;United Kingdom
307NCT01768663
(ClinicalTrials.gov)
January 201311/1/2013A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult SubjectsA Phase 1, Open-Label Study to Examine the Effect of Ciprofloxacin, Itraconazole, and Rifampin on the Pharmacokinetics of Lumacaftor in Combination With Ivacaftor in Healthy Adult SubjectsCystic FibrosisDrug: Lumacaftor;Drug: Ivacaftor;Drug: Ciprofloxacin;Drug: Itraconazole;Drug: RifampinVertex Pharmaceuticals IncorporatedNULLCompleted18 Years55 YearsBoth80Phase 1United States
308EUCTR2012-000389-39-GB
(EUCTR)
25/10/201220/04/2012Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non-G551D CFTR MutationA Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-Term Ivacaftor Treatment in Subjects 6 Years of Age and Older with Cystic Fibrosis and a Non-G551D CFTR Mutation cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Belgium;United Kingdom
309EUCTR2012-000389-39-BE
(EUCTR)
03/09/201226/04/2012Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non-G551D CFTR MutationA Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-TermIvacaftor Treatment in Subjects 6 Years of Age and Older with CysticFibrosis and a Non-G551D CFTR Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Belgium;United Kingdom
310NCT01685801
(ClinicalTrials.gov)
September 20126/9/2012Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR FunctionA Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis, Residual CFTR Function, and FEV1 =40% PredictedCystic FibrosisDrug: Ivacaftor;Drug: Placebo-matched-to-ivacaftor tabletVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll24Phase 2United States
311EUCTR2012-000388-26-BE
(EUCTR)
23/07/201220/04/2012Study of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating MutationA Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 3France;United States;Belgium
312NCT01614457
(ClinicalTrials.gov)
July 20125/6/2012Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have the R117H-CF Transmembrane Conductance Regulator (CFTR) Mutation (KONDUCT)A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have the R117H-CFTR MutationCystic FibrosisDrug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted6 YearsN/AAll70Phase 3United States;United Kingdom;Ireland
313NCT01614470
(ClinicalTrials.gov)
July 20125/6/2012Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating MutationA Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating MutationCystic FibrosisDrug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted6 YearsN/AAll39Phase 3United States;Belgium;France
314EUCTR2012-000387-19-GB
(EUCTR)
11/06/201220/04/2012Study of Ivacaftor in Subjects With Cystic Fibrosis Who Have the R117H-CFTR MutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis who Have the R117H-CFTR Mutation cystic fibrosis
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;United Kingdom
315EUCTR2011-003821-93-GB
(EUCTR)
01/05/201219/04/2012A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR MutationA Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Product Name: VX-661
Product Code: VX-661, VRT-893661
INN or Proposed INN: Not yet assigned
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Product Name: VX-661
Product Code: VX-661, VRT-893661
INN or Proposed INN: Not yet assigned
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Germany;United Kingdom
316NCT01531673
(ClinicalTrials.gov)
February 20121/2/2012Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) MutationA Phase 2, Multicenter, Double-Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic FibrosisDrug: VX-661;Drug: Ivacaftor;Drug: Placebo matched to VX-661;Drug: Placebo matched to ivacaftorVertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll194Phase 2United States;Canada;Germany;United Kingdom
317EUCTR2010-020413-90-BE
(EUCTR)
08/02/201115/10/2010Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
293Phase 2United States;Belgium;Ireland;Australia;Germany;United Kingdom;New Zealand
318EUCTR2010-020413-90-DE
(EUCTR)
06/01/201115/10/2010Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
293Phase 2New Zealand;United Kingdom;Germany;Australia;Belgium;United States
319NCT01262352
(ClinicalTrials.gov)
January 201115/12/2010Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effect of VX-770 on Lung Clearance Index in Subjects With Cystic Fibrosis, the G551D Mutation, and FEV1 >90% PredictedCystic FibrosisDrug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted6 YearsN/AAll21Phase 2United States;Canada;United Kingdom;Ireland
320EUCTR2010-020546-96-GB
(EUCTR)
08/10/201017/08/2010Study of the Effect of VX-770 on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effect of VX-770 on Lung Clearance Index in Subjects with Cystic Fibrosis, the G551D Mutation, and FEV1 >90% Predicted - Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
16Phase 2United Kingdom;Canada;United States
321NCT01225211
(ClinicalTrials.gov)
October 201015/10/2010Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR MutationCystic FibrosisDrug: Lumacaftor;Drug: Ivacaftor;Drug: Lumacaftor Placebo;Drug: Ivacaftor PlaceboVertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll312Phase 2United States;Australia;Belgium;France;Germany;New Zealand;United Kingdom;Ireland
322EUCTR2009-012997-11-DE
(EUCTR)
27/09/201025/06/2010Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and OlderAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
217France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
323EUCTR2009-012997-11-GB
(EUCTR)
08/07/201021/06/2010 Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6 and OlderAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
217 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
324EUCTR2009-012997-11-IE
(EUCTR)
06/07/201005/05/2010Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and OlderAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
217France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
325NCT01117012
(ClinicalTrials.gov)
July 20103/5/2010Rollover Study of VX-770 in Cystic Fibrosis SubjectsAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX-770 in Subjects With Cystic FibrosisCystic FibrosisDrug: IvacaftorVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted6 YearsN/AAll192Phase 3United States;Australia;Canada;Czech Republic;France;Germany;Ireland;United Kingdom
326EUCTR2009-012997-11-CZ
(EUCTR)
22/06/201012/05/2010Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and OlderAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX-770 in Subjects with Cystic Fibrosis - PERSIST Cystic Fibrosis
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
217France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
327EUCTR2008-007479-26-DE
(EUCTR)
25/09/200926/06/2009Study of VX-770 in Cystic Fibrosis Subjects Age 6 to 11 With the G551D MutationA Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 3United States;France;Canada;Ireland;Australia;Germany;United Kingdom
328NCT00953706
(ClinicalTrials.gov)
September 20094/8/2009Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Homozygous for the F508del-CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of VX-770 in Subjects Aged 12 Years and Older With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsTerminated12 YearsN/AAll140Phase 2United States
329EUCTR2008-007416-15-IE
(EUCTR)
11/08/200914/05/2009Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older With the G551D MutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
330EUCTR2008-007479-26-IE
(EUCTR)
11/08/200914/05/2009Study of VX-770 in Cystic Fibrosis Subjects Age 6 to 11 With the G551D MutationA Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Germany;United Kingdom;Canada;France;Ireland;United States;Australia
331NCT00909727
(ClinicalTrials.gov)
August 200926/5/2009Study of Ivacaftor in Cystic Fibrosis Subjects Aged 6 to 11 Years With the G551D MutationA Phase 3, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX-770 in Subjects Aged 6 to 11 Years With Cystic Fibrosis and the G551D MutationCystic FibrosisDrug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted6 Years11 YearsAll52Phase 3United States;Australia;Canada;France;Germany;Ireland;United Kingdom
332EUCTR2008-007479-26-GB
(EUCTR)
27/07/200922/05/2009Study of VX-770 in Cystic Fibrosis Subjects Age 6 to 11 With the G551D MutationA Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Ireland;Australia;Germany;United Kingdom
333EUCTR2008-007416-15-GB
(EUCTR)
27/07/200922/05/2009Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older With the G551D MutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
334NCT00909532
(ClinicalTrials.gov)
June 200926/5/2009Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D MutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-770 in Subjects With Cystic Fibrosis and the G551D MutationCystic FibrosisDrug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted12 YearsN/AAll167Phase 3United States;Australia;Canada;Czech Republic;France;Germany;Ireland;United Kingdom
335NCT00457821
(ClinicalTrials.gov)
May 20075/4/2007Safety Study of Ivacaftor in Subjects With Cystic FibrosisA Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects With Genotype G551DCystic FibrosisDrug: Ivacaftor 25 mg/75 mg;Drug: Ivacaftor 75 mg/150 mg;Drug: Ivacaftor 150 mg or 250 mg;Drug: PlaceboVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted18 YearsN/AAll39Phase 2United States;Canada;Germany
336EUCTR2018-004652-38-DE
(EUCTR)
24/06/2019A Study Evaluating the Long-term Safety of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy Cystic Fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100 mg VX-445 /50 mg TEZ/75 mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Trikafta
Product Name: 100 mg ELX (VX-445) / 50 mg TEZ / 75 mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
481Phase 3Switzerland;United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Germany;United Kingdom
337EUCTR2017-001309-34-Outside-EU/EEA
(EUCTR)
29/03/2017Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung DiseaseA Phase 3b, Open-Label Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Cystic Fibrosis and Advanced Lung Disease, Homozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: lumacaftor/ivacaftor
Product Name: lumacaftor/ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
46Phase 3United States
338EUCTR2008-007416-15-DE
(EUCTR)
29/05/2009Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older With the G551D MutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
339EUCTR2019-001827-11-GB
(EUCTR)
11/12/2019Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and OlderA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445 / TEZ / IVA FDC
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: VX-445 / TEZ / IVA FDC
Product Code: VX-445 / TEZ / IVA
Vertex Pharmaceuticals IncorporatedNULLNA Female: yes
Male: yes
56 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom;Australia;Ireland;Canada;United States
340EUCTR2017-000540-18-FR
(EUCTR)
01/08/2017Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Subjects With Cystic Fibrosis (CF) Who Have Previously Discontinued Orkambi Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Germany
341EUCTR2015-001267-39-FR
(EUCTR)
04/12/2015A study to assess the efficacy and safety of ivacaftor in children aged 3 to 5 with Cystic Fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3b, 2-part, Randomized, Double-blind, Placebo-controlled Crossover Study With a Long term Open-label Period to Investigate Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
50Phase 3France;Canada;Australia;United Kingdom
342EUCTR2021-005320-38-PT
(EUCTR)
02/02/2022Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del MutationA Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg ELX/50mg TEZ /75mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 75-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
270Phase 3France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy
343EUCTR2018-002835-76-BE
(EUCTR)
25/07/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
344EUCTR2021-000694-85-BE
(EUCTR)
21/10/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
345EUCTR2009-010261-23-Outside-EU/EEA
(EUCTR)
06/06/2011Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older Homozygous for the F508del-CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of VX-770 in Subjects Aged 12 Years and Older With Cystic Fibrosis who are Homozygous for the F508del-CFTR Mutation - DISCOVER Cystic Fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770; VRT-813077
INN or Proposed INN: ivacaftor (proposed INN)
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
140Phase 2United States
346EUCTR2021-005320-38-BE
(EUCTR)
05/01/2022Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del MutationA Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg ELX/50mg TEZ /75mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 75-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
270Phase 3France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy
347EUCTR2020-004885-21-NL
(EUCTR)
22/09/2021A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects With Cystic FibrosisA Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Kaftrio
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kaftrio
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
143Phase 3Czechia;Spain;Belgium;Netherlands
348EUCTR2020-003170-44-NL
(EUCTR)
09/11/2020A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose MetabolismA Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770)
INN or Proposed INN: Elexacaftor
INN or Proposed INN: Tezacaftor
INN or Proposed INN: IVACAFTOR
Trade Name: Ivacaftor
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
60Phase 3France;Czechia;Spain;Belgium;Australia;Netherlands;Italy
349EUCTR2020-003170-44-FR
(EUCTR)
22/10/2020A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose MetabolismA Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770)
INN or Proposed INN: Elexacaftor
INN or Proposed INN: Tezacaftor
INN or Proposed INN: IVACAFTOR
Trade Name: Ivacaftor
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
60Phase 3France;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy
350EUCTR2018-000183-28-FR
(EUCTR)
12/12/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
351EUCTR2021-001628-16-BE
(EUCTR)
06/08/2021A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Subjects with Cystic Fibrosis (CF)A Phase 3b Open-label Study Evaluating the Effects of Elexacaftor/Tezacaftor/Ivacaftor on Cough and Physical Activity in Cystic Fibrosis Subjects 12 Years of Age and Older Who Are Heterozygous for the F508delMutation and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
100Phase 3Canada;Spain;Belgium;Australia
352EUCTR2017-004133-82-DE
(EUCTR)
08/03/2018A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor/Ivacaftor/100mg/150mg
Product Code: VX-661/VX-770 (TEZ/IVA)
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Spain;Ireland;Australia;Germany;United Kingdom
353EUCTR2019-001735-31-BE
(EUCTR)
08/07/2019A study to evaluate the safety and efficacy of VX-445 / Tezacaftor / Ivacaftor in patients suffering from Cystic FibrosisA Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del - A Study Evaluating the Efficacy & Safety of VX-445/Tezacaftor/Ivacafto in Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: ELEXACAFTOR
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
158Phase 3Belgium;Australia;Germany;United Kingdom
354EUCTR2017-004132-11-PL
(EUCTR)
18/04/2018A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
360Phase 3United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
355EUCTR2018-000185-11-SE
(EUCTR)
02/07/2018A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Trikafta
Product Name: 100 mg ELX /50 mg TEZ /75 mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
460Phase 3United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
356EUCTR2017-000672-28-Outside-EU/EEA
(EUCTR)
27/03/2017Study of the Effect of VX-770 on Hyperpolarized Helium-3 MagneticResonance Imaging in Subjects With Cystic Fibrosis and the G551DMutationA Phase 2, Single-Blind, Placebo-Controlled Study to Evaluate the Effectof VX-770 on Hyperpolarized Helium-3 Magnetic Resonance Imaging inSubjects With Cystic Fibrosis, the G551D Mutation, and FEV1 =40%Predicted cystic fibrosis
MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
17Phase 2United States
357EUCTR2015-001997-16-DE
(EUCTR)
24/04/2017A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have a CFTR Gating Mutation Cystic Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Ireland;Germany;United Kingdom
358EUCTR2016-004479-35-IE
(EUCTR)
19/02/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
359EUCTR2018-001695-38-IE
(EUCTR)
28/08/2019Evaluation of VX-445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 YearsA Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445 / TEZ / IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: VX-445 / TEZ / IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Product Name: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
56Phase 3United States;Canada;Ireland;Australia;United Kingdom
360EUCTR2019-000833-37-BE
(EUCTR)
25/07/2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
361EUCTR2021-000694-85-IE
(EUCTR)
29/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
362EUCTR2021-005320-38-NL
(EUCTR)
23/02/2022Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del MutationA Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg ELX/50mg TEZ /75mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 75-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
270Phase 3Portugal;France;Spain;Belgium;Austria;Germany;Netherlands;Switzerland;Italy
363EUCTR2017-000673-37-Outside-EU/EEA
(EUCTR)
27/03/2017Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR FunctionA Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis, Residual CFTR Function, and FEV1 =40% Predicted cystic fibrosis
MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
24Phase 2United States
364EUCTR2018-002835-76-FR
(EUCTR)
12/07/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
250Phase 3United States;France;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
365EUCTR2021-000712-31-IE
(EUCTR)
29/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
400Phase 3Portugal;United States;Czechia;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden
366EUCTR2021-005320-38-DE
(EUCTR)
16/12/2021Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del MutationA Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg ELX/50mg TEZ /75mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 75-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
270Phase 3France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy
367EUCTR2018-004652-38-PL
(EUCTR)
06/09/2019A Study Evaluating the Long-term Safety of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy Cystic Fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 /50-mg TEZ/75-mg
Product Code: VX-445 /TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
458Phase 3United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Germany;United Kingdom;Switzerland
368EUCTR2020-003170-44-BE
(EUCTR)
16/10/2020A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose MetabolismA Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770)
INN or Proposed INN: Elexacaftor
INN or Proposed INN: Tezacaftor
INN or Proposed INN: IVACAFTOR
Trade Name: Ivacaftor
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
60Phase 3France;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy
369EUCTR2020-004885-21-BE
(EUCTR)
15/09/2021A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects With Cystic FibrosisA Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Kaftrio
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kaftrio
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
143Phase 3Czechia;Czech Republic;Canada;Spain;Belgium;Australia;Netherlands
370EUCTR2021-000712-31-CZ
(EUCTR)
23/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
400Phase 3United States;Portugal;Czechia;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden
371EUCTR2015-004841-13-FR
(EUCTR)
23/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Ivacaftor
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic saline
INN or Proposed INN: 4.2% NaCl/inhalation solution
Vertex Pharmaceuticals Inc.NULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Czech Republic;Ireland;United Kingdom
372EUCTR2020-001404-42-FR
(EUCTR)
16/11/2020A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypesA Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
108Phase 3France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland
373EUCTR2020-001404-42-DE
(EUCTR)
01/10/2020A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypesA Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
108Phase 3Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland;France
374EUCTR2017-001379-21-IE
(EUCTR)
26/07/2017A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
75Phase 3United States;Canada;Ireland;Germany;United Kingdom
375EUCTR2018-000185-11-FR
(EUCTR)
24/01/2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100 mg VX-445/50 mg TEZ /75 mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNA Female: yes
Male: yes
460 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
376EUCTR2018-000185-11-DE
(EUCTR)
03/07/2018A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100 mg VX-445/50 mg TEZ /75 mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Trikafta
Product Name: 100-mg ELX (VX-445) / 50-mg TEZ / 75-mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-c
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
460Phase 3United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
377EUCTR2015-001644-11-SE
(EUCTR)
05/11/2015Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
256Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
378EUCTR2015-000543-16-FR
(EUCTR)
07/07/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
379EUCTR2017-001078-41-Outside-EU/EEA
(EUCTR)
27/03/2017A study in people with cystic fibrosis (a rare pulmonary disease) to assess the pharmacokinetics and safety of a combination of two experimental drugsA Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: lumacaftor/ivacaftor
Product Name: lumacaftor/ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
58Phase 3United States;Canada
380EUCTR2017-002968-40-DE
(EUCTR)
05/04/2018A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Symdeko
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symkevi
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symdeko
Product Name: Ivacaftor 75 mg
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor 150 mg
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
381EUCTR2017-002968-40-FR
(EUCTR)
13/06/2018A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
121Phase 3Switzerland;United Kingdom;Germany;Australia;Denmark;Ireland;Belgium;Poland;Canada;France;United States
382EUCTR2021-000694-85-AT
(EUCTR)
27/10/2021A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
383EUCTR2017-001379-21-DE
(EUCTR)
01/08/2017A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Kalydeco
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
75Phase 3United States;Canada;Ireland;Germany;United Kingdom
384EUCTR2021-005320-38-AT
(EUCTR)
07/01/2022Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del MutationA Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg ELX/50mg TEZ /75mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 75-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
270Phase 3France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy
385EUCTR2020-002239-31-DE
(EUCTR)
20/12/2021Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Subjects 2 Years and OlderA Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 80mg ELX / 40mg TEZ / 60mg IVA
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Product Name: IVACAFTOR 59.5mg
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 100g ELX / 50mg TEZ / 75mg IVA
Product Code: ELX/TEZ/IVA
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
Trade Name: Kalydeco
Product Name: IVACAFTOR 75mg
Product Code: VX-77
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
70Phase 3United States;Canada;Australia;Germany;United Kingdom
386EUCTR2015-001997-16-GB
(EUCTR)
07/03/2016A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Ivacaftor-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
35Phase 3United States;Canada;Ireland;Germany;United Kingdom