Trials / Completed
CompletedNCT05882357
Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age
A Phase 3, Open-label Study Evaluating the Pharmacokinetics, Safety, and Tolerability of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 12 to Less Than 24 Months of Age
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Months – 24 Months
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the pharmacokinetics (PK), safety, tolerability, pharmacodynamics (PD), and efficacy of ELX/TEZ/IVA in CF subjects 12 to less than (\<) 24 months of age.
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
- 2023-06-27
- Primary completion
- 2025-09-04
- Completion
- 2025-09-04
- First posted
- 2023-05-31
- Last updated
- 2025-10-06
Locations
19 sites across 7 countries: Australia, Canada, Denmark, Germany, Netherlands, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05882357. Inclusion in this directory is not an endorsement.