299. 嚢胞性線維症
[臨床試験数:1,592,薬物数:1,539(DrugBank:255),標的遺伝子数:81,標的パスウェイ数:162

Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Search in Page e.g. "Phase 3", "Not recruiting", "Japan"
39 trials found
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-002496-18-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
2EUCTR2018-002496-18-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
3EUCTR2018-002496-18-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
4EUCTR2017-004133-82-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 States;Spain;Ireland;Australia;Germany;United Kingdom
5EUCTR2017-004133-82-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
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
6EUCTR2018-000126-55-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
7EUCTR2017-000797-11-NL
(EUCTR)
06/10/201730/05/2017A Study of VX-445 in Healthy Subjects and Subjects with Cystic FibrosisA Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;Belgium;Australia;Netherlands
8EUCTR2017-000797-11-BE
(EUCTR)
28/08/201715/06/2017A Study of VX-445 in Healthy Subjects and Subjects with Cystic FibrosisA Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Product Name: Deuterated Ivacaftor
Product Code: VX-561 (CTP-656)
INN or Proposed INN: VX-561
Other descriptive name: VX-561
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
104Phase 2United States;Belgium;Australia;Netherlands
9EUCTR2016-003585-11-GB
(EUCTR)
10/08/201710/07/2017Study to Evaluate the Safety and Efficacy of VX-659 drug in combination with other drugs in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659
Product Code: VX-659
INN or Proposed INN: VX-659
Other descriptive name: VX-659
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor/Ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: TEZACAFTOR
Product Name: Deuterated Ivacaftor
Product Code: VX-561 (CTP-656)
INN or Proposed INN: Deuterated Ivacaftor
Other descriptive name: VX-561 (CTP-656)
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
105Phase 2United States;Ireland;Israel;United Kingdom
10EUCTR2016-000454-36-NL
(EUCTR)
05/05/201702/11/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
11EUCTR2016-000454-36-BE
(EUCTR)
24/01/201725/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Spain;Belgium;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
12EUCTR2016-000454-36-ES
(EUCTR)
18/01/201726/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
13EUCTR2016-000454-36-IT
(EUCTR)
16/01/201727/02/2018A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVACAFTOR
VERTEX PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
14EUCTR2016-000454-36-DE
(EUCTR)
04/01/201712/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
15EUCTR2016-000454-36-AT
(EUCTR)
03/01/201707/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Australia;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
16EUCTR2016-000454-36-DK
(EUCTR)
18/11/201610/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Austria;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
17EUCTR2014-004838-25-DE
(EUCTR)
16/08/201617/05/2016A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
155Phase 3United States;France;Canada;Belgium;Ireland;Austria;Germany;United Kingdom;Italy
18EUCTR2014-004788-18-BE
(EUCTR)
03/06/201603/03/2016A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland
19EUCTR2014-004838-25-AT
(EUCTR)
02/06/201620/04/2016A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
155Phase 3France;United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
20EUCTR2014-004827-29-ES
(EUCTR)
12/01/201618/11/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
21EUCTR2014-004837-13-DE
(EUCTR)
15/12/201521/04/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
22EUCTR2014-004827-29-GB
(EUCTR)
03/11/201505/08/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Symkevi
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
23EUCTR2014-004787-37-ES
(EUCTR)
26/10/201525/08/2015A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs.A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Spain;Austria;Australia;Israel;Germany
24EUCTR2014-004787-37-DE
(EUCTR)
24/09/201519/06/2015A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs.A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Spain;Austria;Australia;Israel;Germany
25EUCTR2014-004787-37-AT
(EUCTR)
21/09/201518/06/2015A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs.A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Spain;Australia;Austria;Israel;Germany
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
26EUCTR2014-004827-29-IT
(EUCTR)
01/09/201508/07/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
27EUCTR2014-004838-25-BE
(EUCTR)
31/07/201526/05/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
28EUCTR2014-004788-18-DE
(EUCTR)
24/07/201531/03/2015A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland
29EUCTR2014-004837-13-IT
(EUCTR)
22/07/201527/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
30EUCTR2014-004788-18-IT
(EUCTR)
15/07/201519/03/2015A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
31EUCTR2014-004788-18-NL
(EUCTR)
10/07/201508/04/2015A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3France;United States;Canada;Belgium;Australia;Israel;Germany;Netherlands;Italy;United Kingdom
32EUCTR2014-004837-13-NL
(EUCTR)
10/07/201508/04/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Germany;Netherlands;Italy;United Kingdom;Switzerland;Sweden
33EUCTR2014-004837-13-ES
(EUCTR)
02/07/201515/06/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
34EUCTR2014-004837-13-DK
(EUCTR)
24/06/201526/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
35EUCTR2014-004838-25-IE
(EUCTR)
22/06/201510/04/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
155Phase 3France;United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
36EUCTR2014-004837-13-IE
(EUCTR)
11/06/201505/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
37EUCTR2014-004838-25-IT
(EUCTR)
20/05/201530/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Ireland;Austria;Germany;United Kingdom;Italy
38EUCTR2014-004837-13-SE
(EUCTR)
24/04/201506/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
39EUCTR2017-004133-82-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