Trials / Completed
CompletedNCT04545515
A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Particpants 6 Years and Older and F/MF Genotypes
A Phase 3b Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 120 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
The study evaluates the long-term safety and efficacy of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) triple combination (TC) in participants with CF who are 6 years of age and older with F/MF genotypes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ELX/TEZ/IVA | Fixed dose combination (FDC) tablets for oral administration. |
| DRUG | IVA | Tablet for oral administration. |
Timeline
- Start date
- 2021-01-11
- Primary completion
- 2023-03-24
- Completion
- 2023-03-24
- First posted
- 2020-09-11
- Last updated
- 2024-05-08
- Results posted
- 2024-05-08
Locations
34 sites across 10 countries: Australia, Canada, Denmark, France, Germany, Israel, Netherlands, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04545515. Inclusion in this directory is not an endorsement.