Trials / Active Not Recruiting
Active Not RecruitingNCT06460506
Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Participants 12 Months of Age and Older
A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 12 Months of Age and Older
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Months
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to evaluate the long-term safety, tolerability, efficacy, and pharmacodynamics (PD) of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ELX/TEZ/IVA | Fixed-dose combination granules for oral administration. |
| DRUG | IVA | Granules for oral administration |
Timeline
- Start date
- 2024-11-21
- Primary completion
- 2027-09-30
- Completion
- 2027-09-30
- First posted
- 2024-06-14
- Last updated
- 2025-10-06
Locations
18 sites across 7 countries: Australia, Canada, Denmark, Germany, Netherlands, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06460506. Inclusion in this directory is not an endorsement.