299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,696 / 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
| 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 | EUCTR2018-000185-11-AT (EUCTR) | 27/02/2019 | 19/10/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 2 | EUCTR2018-000185-11-GR (EUCTR) | 20/12/2018 | 28/11/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 3 | EUCTR2018-000185-11-NL (EUCTR) | 14/11/2018 | 19/09/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Trifakta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 4 | EUCTR2018-000185-11-GB (EUCTR) | 19/10/2018 | 04/07/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 5 | EUCTR2018-000185-11-CZ (EUCTR) | 15/10/2018 | 09/07/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 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 Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 6 | EUCTR2018-000185-11-IT (EUCTR) | 04/10/2018 | 22/01/2021 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation - NA | 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: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: [ELX/TEZ/IVA] INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 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 INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden |