IVACAFTOR ( DrugBank: Ivacaftor )
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 | 363 |
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
Showing 1 to 10 of 363 diseases
No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | EUCTR2021-000694-85-DK (EUCTR) | 17/03/2022 | 27/09/2021 | A 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 Mutation A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous fo ... | 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 A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 C ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | 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 Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: teza ... | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Denmark;Australia;Germany;Netherlands;Norway;Sweden United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Be ... | ||
2 | NCT05274269 (ClinicalTrials.gov) | March 2022 | 1/3/2022 | Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor(ELX/TEZ/IVA) in Cystic Fibrosi ... | A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of E ... | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA;Other: Placebo (matched to ELX/TEZ/IVA);Other: Placebo (matched to IVA) | Vertex Pharmaceuticals Incorporated | NULL | Not yet recruiting | 6 Years | N/A | All | 270 | Phase 3 | NULL |
3 | EUCTR2021-005320-38-ES (EUCTR) | 21/01/2022 | 01/12/2021 | Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation | A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of E ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/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: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaft ... | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | France;Portugal;Belgium;Spain;Austria;Netherlands;Germany;Switzerland;Italy | ||
4 | EUCTR2021-000712-31-SE (EUCTR) | 18/01/2022 | 22/09/2021 | A 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 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508 ... | 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) A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 C ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | 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 Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: teza ... | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia; ... | ||
5 | NCT05153317 (ClinicalTrials.gov) | January 17, 2022 | 29/11/2021 | Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Ye ... | A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Iv ... | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Enrolling by invitation | 2 Years | N/A | All | 70 | Phase 3 | United States |
6 | EUCTR2021-000712-31-PT (EUCTR) | 14/01/2022 | 16/11/2021 | A 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 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508 ... | 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) A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 C ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | 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 Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: teza ... | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Czechia;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden United States;Portugal;Czechia;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom; ... | ||
7 | NCT05111145 (ClinicalTrials.gov) | January 14, 2022 | 27/10/2021 | A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF) A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftorin Participants With Cystic Fibrosi ... | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/IvacaftorCombination The ... | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Enrolling by invitation | 12 Years | N/A | All | 195 | Phase 3 | Australia;Spain |
8 | EUCTR2021-000712-31-DE (EUCTR) | 12/01/2022 | 23/09/2021 | A 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 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508 ... | 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) A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 C ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | 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 Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: teza ... | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia; ... | ||
9 | EUCTR2021-000694-85-IT (EUCTR) | 21/12/2021 | 15/10/2021 | A 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 Mutation A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous fo ... | 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 - A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous fo A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 C ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | 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 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: [VX-770] INN or Proposed INN: ivacaftor Produ ... | VERTEX PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Be ... | ||
10 | EUCTR2021-000694-85-DE (EUCTR) | 20/12/2021 | 27/09/2021 | A 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 Mutation A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous fo ... | 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 A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 C ... | 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] Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;Sy ... | 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 Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: teza ... | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Be ... |