Trials / Completed
CompletedNCT03537651
A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Participants With an F508del CFTR Mutation
A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 130 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluates the long-term safety and tolerability of tezacaftor in combination with ivacaftor (TEZ/IVA) in participants with cystic fibrosis (CF) aged 6 years and older, homozygous or heterozygous for the F508del mutation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TEZ/IVA | Fixed-dose combination tablet for oral administration. |
| DRUG | IVA | Tablet for oral administration. |
Timeline
- Start date
- 2018-04-25
- Primary completion
- 2020-10-28
- Completion
- 2023-09-29
- First posted
- 2018-05-25
- Last updated
- 2024-04-19
- Results posted
- 2021-11-26
Locations
55 sites across 11 countries: United States, Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Poland, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03537651. Inclusion in this directory is not an endorsement.