Trials / Recruiting
RecruitingNCT05422222
Evaluation of VX-121/Tezacaftor/Deutivacaftor in Cystic Fibrosis (CF) Participants 1 Through 11 Years of Age
A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-121/Tezacaftor/Deutivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 1 Through 11 Years of Age
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 210 (estimated)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 1 Year – 11 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the pharmacokinetics, safety, tolerability and efficacy of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in CF participants with at least 1 triple combination responsive (TCR) mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VX-121/TEZ/D-IVA | Fixed-dose combination for oral administration. |
Timeline
- Start date
- 2022-06-21
- Primary completion
- 2030-06-30
- Completion
- 2030-06-30
- First posted
- 2022-06-16
- Last updated
- 2026-03-30
Locations
38 sites across 10 countries: United States, Australia, Canada, France, Germany, Netherlands, New Zealand, Sweden, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05422222. Inclusion in this directory is not an endorsement.