Symdeko ( 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 | 4 |
299. 嚢胞性線維症
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 | NCT03587961 (ClinicalTrials.gov) | August 1, 2019 | 3/7/2018 | Personalized Theratyping Trial | Personalized Theratyping Trial | Cystic Fibrosis | Drug: Symdeko | University of Alabama at Birmingham | NULL | Recruiting | 6 Years | N/A | All | 20 | Early Phase 1 | United States |
| 2 | NCT03624101 (ClinicalTrials.gov) | December 1, 2018 | 7/8/2018 | Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations | Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations | Cystic Fibrosis | Drug: Trikafta;Drug: symdeko/Trikafta;Drug: Ivacaftor/Trikafta | University of Alabama at Birmingham | NULL | Recruiting | 18 Years | N/A | All | 2 | Phase 4 | United States |
| 3 | EUCTR2017-002968-40-DE (EUCTR) | 05/04/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-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] | Trade Name: Symdeko Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symdeko Product Name: Ivacaftor 75 mg Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor 150 mg Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | |||
| 4 | EUCTR2020-000689-40-Outside-EU/EEA (EUCTR) | 25/02/2020 | A Study to Evaluate the Relative Bioavailability of Tezacaftor/Ivacaftor Granules | A Phase 1, Open-label, Randomized, Crossover Study to Evaluate the Relative Bioavailability of a Granule Formulation of Tezacaftor and Ivacaftor Compared to a Fixed-dose Combination Tablet in Healthy Adult Subjects | 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: tezacaftor/ivacaftor Product Code: VX-661/VX-770 INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Symdeko Product Name: tezacaftor/ivacaftor Product Code: VX-661/VX-770 INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | Phase 1 | United States |