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

  
19 trials found
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
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
11EUCTR2018-003970-28-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
12EUCTR2018-003970-28-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
13EUCTR2018-003970-28-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
14EUCTR2018-003970-28-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
15EUCTR2021-000694-85-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
16EUCTR2021-000712-31-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
17EUCTR2021-000694-85-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
18EUCTR2021-000694-85-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
19EUCTR2021-000712-31-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