Trials / Active Not Recruiting
Active Not RecruitingNCT05444257
A Study Evaluating the Long-term Safety and Efficacy of VX-121 Combination Therapy
A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-121/TEZ/D-IVA Combination Therapy in Subjects With Cystic Fibrosis
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 822 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with cystic fibrosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VX-121/TEZ/D-IVA | Fixed-dose combination tablets for oral administration. |
Timeline
- Start date
- 2022-11-08
- Primary completion
- 2026-10-30
- Completion
- 2026-10-30
- First posted
- 2022-07-05
- Last updated
- 2025-09-05
Locations
195 sites across 23 countries: United States, Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05444257. Inclusion in this directory is not an endorsement.