100mg vx-445/50mg tez /75mg iva fdc (DrugBank: -)
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 | 1 |
| 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 | EUCTR2018-000184-89-GB (EUCTR) | 27/09/2018 | 04/07/2018 | A Phase 3 Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F). | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | 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 VX-445/50mg TEZ /75mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor Product Name: 100 mg TEZ/150 mg IVA FDC Product Code: TEZ/IVA INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Belgium;Netherlands;United Kingdom |