Trials / Completed
CompletedNCT03460990
A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy of VX-659 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VX-659/TEZ/IVA | Participants received VX-659/TEZ/IVA orally once daily in the morning. |
| DRUG | TEZ/IVA | Participants received TEZ/IVA orally once daily in the morning. |
| DRUG | IVA | Participants received IVA orally once daily in the evening. |
| DRUG | Placebo | Participants received placebo matched TEZ/IVA orally once daily in the morning. |
| DRUG | Placebo | Participants received placebo matched to VX-659/TEZ/IVA orally once daily in the morning. |
Timeline
- Start date
- 2018-05-01
- Primary completion
- 2018-09-26
- Completion
- 2018-10-08
- First posted
- 2018-03-09
- Last updated
- 2019-10-17
- Results posted
- 2019-10-17
Locations
46 sites across 6 countries: United States, Australia, Germany, Ireland, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03460990. Inclusion in this directory is not an endorsement.