Trials / Completed
CompletedNCT03525574
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 507 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The study evaluates the long-term safety and tolerability of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ELX/TEZ/IVA | Fixed-dose combination (FDC) tablet for oral administration. |
| DRUG | IVA | Tablet for oral administration. |
Timeline
- Start date
- 2018-10-09
- Primary completion
- 2023-01-09
- Completion
- 2023-01-09
- First posted
- 2018-05-15
- Last updated
- 2025-09-24
- Results posted
- 2024-05-08
Locations
110 sites across 13 countries: United States, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Italy, Netherlands, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03525574. Inclusion in this directory is not an endorsement.