Trials / Completed
CompletedNCT04043806
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 458 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).
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
- 2019-08-09
- Primary completion
- 2022-12-14
- Completion
- 2022-12-14
- First posted
- 2019-08-02
- Last updated
- 2023-07-06
- Results posted
- 2023-07-06
Locations
97 sites across 11 countries: United States, Australia, Canada, Denmark, Germany, Ireland, Israel, Poland, Spain, Switzerland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04043806. Inclusion in this directory is not an endorsement.