299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details


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

  
24 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
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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
2EUCTR2021-000712-31-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
3EUCTR2021-000712-31-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
4EUCTR2021-000712-31-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
5EUCTR2021-000694-85-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
6EUCTR2021-000694-85-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
7EUCTR2021-000694-85-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
8EUCTR2021-000694-85-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
9EUCTR2021-000694-85-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
10EUCTR2021-000694-85-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
11NCT05076149
(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
12NCT05033080
(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
13EUCTR2018-002496-18-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
14EUCTR2018-002496-18-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
15EUCTR2018-002496-18-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
16NCT03912233
(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
17EUCTR2018-002496-18-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
18NCT03768089
(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
19EUCTR2018-000126-55-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
20EUCTR2021-000712-31-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
21EUCTR2021-000712-31-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
22EUCTR2021-000694-85-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
23EUCTR2021-000694-85-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
24EUCTR2021-000694-85-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