Trials / Completed
CompletedNCT05153317
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older
A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 2 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the long term safety, tolerability, efficacy and pharmacodynamics of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) in CF participants 2 years of age and older.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ELX/TEZ/IVA | Fixed-dose combination granules or tablets for oral administration. |
| DRUG | IVA | Granules or tablets for oral administration. |
Timeline
- Start date
- 2022-01-17
- Primary completion
- 2026-01-29
- Completion
- 2026-01-29
- First posted
- 2021-12-10
- Last updated
- 2026-03-03
Locations
22 sites across 5 countries: United States, Australia, Canada, Germany, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05153317. Inclusion in this directory is not an endorsement.