Tezacaftor (TEZ) ( DrugBank: Tezacaftor )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症9

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-000797-11-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
2EUCTR2016-000454-36-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
3EUCTR2016-000454-36-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
4EUCTR2016-000454-36-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
5EUCTR2016-000454-36-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
6EUCTR2016-000454-36-GB
(EUCTR)
10/01/201707/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
198 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
7EUCTR2016-000454-36-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
8EUCTR2016-000454-36-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
9EUCTR2016-000454-36-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