Trials / Terminated
TerminatedNCT03447262
A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy
A Phase 3, Open-label Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 484 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the long-term safety and tolerability of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous or heterozygous for the F508del mutation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VX-659/TEZ/IVA | Fixed-dose combination tablets for oral administration qd in the morning. |
| DRUG | IVA | IVA tablet qd in the evening. |
Timeline
- Start date
- 2018-07-13
- Primary completion
- 2020-09-09
- Completion
- 2020-09-09
- First posted
- 2018-02-27
- Last updated
- 2022-01-25
- Results posted
- 2022-01-25
Locations
100 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 NCT03447262. Inclusion in this directory is not an endorsement.