299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,695 / 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
| 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 | EUCTR2021-005914-33-AT (EUCTR) | 18/08/2022 | 15/06/2022 | Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor Long-term Safety and Efficacy in Subjects Without F508del | A Phase 3 Open-label Study Evaluating the Longterm Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes - Study to Evaluate Elx/Tez/Iva Long-term Safety and Efficacy in Subjects Without F508del | 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: Kaftrio 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 Trade Name: Kalydeco Product Name: 150mg Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: 75-mg Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Trade Name: Kaftrio Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Norway;Netherlands;Germany;Sweden | ||
| 2 | EUCTR2021-005320-38-SE (EUCTR) | 25/04/2022 | 04/03/2022 | 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 | 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: 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 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Hungary;Belgium;Poland;Germany;Netherlands;Norway;Sweden | ||
| 3 | EUCTR2021-005320-38-NL (EUCTR) | 21/04/2022 | 23/02/2022 | 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 | 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: 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 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | Portugal;France;Spain;Belgium;Austria;Germany;Netherlands;Switzerland;Italy;Sweden | ||
| 4 | EUCTR2021-005320-38-PT (EUCTR) | 18/03/2022 | 02/02/2022 | 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 | 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: 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 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy | ||
| 5 | EUCTR2021-005320-38-AT (EUCTR) | 15/03/2022 | 07/01/2022 | 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 | 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: 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 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | France;Portugal;Spain;Belgium;Austria;Norway;Netherlands;Germany;Switzerland;Italy;Sweden | ||
| 6 | 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 | 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: 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 | 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 | ||
| 7 | EUCTR2021-005320-38-NO (EUCTR) | 15/03/2022 | 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 | 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: 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 | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 270 | Phase 3 | Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Hungary;Belgium;Poland;Norway;Germany;Netherlands;Sweden | |||
| 8 | EUCTR2021-005914-33-SE (EUCTR) | 16/05/2022 | Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor Long-term Safety and Efficacy in Subjects Without F508del | A Phase 3 Open-label Study Evaluating the Longterm Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects With Non-F508del CFTR Genotypes - Study to Evaluate Elx/Tez/Iva Long-term Safety and Efficacy in Subjects Without F508del | 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: Kaftrio 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 Trade Name: Kalydeco Product Name: 150mg Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: 75-mg Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Trade Name: Kaftrio Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 270 | Phase 3 | Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Norway;Netherlands;Germany;Sweden | |||
| 9 | EUCTR2021-005320-38-BE (EUCTR) | 05/01/2022 | 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 | 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: 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 | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 270 | Phase 3 | France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy | |||
| 10 | EUCTR2021-005320-38-CZ (EUCTR) | 11/03/2022 | 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 | 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: 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 | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 270 | Phase 3 | Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany;Netherlands;Norway;Sweden | |||
| 11 | EUCTR2021-005320-38-DE (EUCTR) | 16/12/2021 | 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 | 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: 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 | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 270 | Phase 3 | Portugal;Czechia;Spain;Austria;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Norway;Germany;Netherlands;Sweden |