Trials / Completed
CompletedNCT04362761
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
A Phase 3b Open-label Extension Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 172 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous for F508del.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ELX/TEZ/IVA | Fixed-dose combination (FDC) tablet for oral administration. |
| DRUG | IVA | Tablet for oral administration. |
Timeline
- Start date
- 2020-05-04
- Primary completion
- 2022-12-21
- Completion
- 2022-12-21
- First posted
- 2020-04-27
- Last updated
- 2023-07-28
- Results posted
- 2023-07-28
Locations
29 sites across 4 countries: Australia, Belgium, Germany, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04362761. Inclusion in this directory is not an endorsement.