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

  
36 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
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Recruitment_
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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PhaseCountries
1NCT04105972
(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
2NCT04058353
(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
3EUCTR2017-004134-29-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
4NCT03912233
(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
5EUCTR2017-002968-40-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
6EUCTR2018-000184-89-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
7EUCTR2016-004479-35-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
8EUCTR2017-004134-29-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
9EUCTR2018-000184-89-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
10EUCTR2018-000184-89-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
11EUCTR2017-004134-29-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
12EUCTR2017-004134-29-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
13EUCTR2016-004479-35-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
14NCT03525548
(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
15EUCTR2016-004479-35-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
16EUCTR2016-004479-35-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
17EUCTR2017-004134-29-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
18EUCTR2017-004133-82-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
19NCT03559062
(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
20EUCTR2017-004134-29-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
21EUCTR2017-004133-82-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
22EUCTR2017-004133-82-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
23NCT03460990
(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
24NCT03537651
(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
25EUCTR2016-004479-35-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
26EUCTR2016-004479-35-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
27NCT03768089
(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
28EUCTR2017-000540-18-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
29NCT03224351
(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
30NCT03150719
(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
31NCT03227471
(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
32NCT02953314
(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
33NCT02565914
(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
34EUCTR2017-000540-18-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
35EUCTR2017-004133-82-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
36EUCTR2016-004479-35-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