100 mg VX-445 /50 mg TEZ/75 mg 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 |
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. | 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 | EUCTR2018-004652-38-DE (EUCTR) | 24/06/2019 | A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | Cystic Fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100 mg VX-445 /50 mg TEZ/75 mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Trikafta Product Name: 100 mg ELX (VX-445) / 50 mg TEZ / 75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Ivacaftor Other descriptive name: IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 481 | Phase 3 | Switzerland;United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Germany;United Kingdom |