Trials / Completed
CompletedNCT03525548
A Study of VX-445 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-445 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
- 113 (actual)
- Sponsor
- Vertex Pharmaceuticals Incorporated · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy of VX-445 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-445/TEZ/IVA | Participants received VX-445/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 to VX-445/TEZ/IVA orally once daily in the morning. |
| DRUG | Placebo | Participants received placebo matched TEZ/IVA orally once daily in the morning. |
Timeline
- Start date
- 2018-08-03
- Primary completion
- 2018-12-28
- Completion
- 2018-12-28
- First posted
- 2018-05-15
- Last updated
- 2020-01-27
- Results posted
- 2020-01-27
Locations
44 sites across 4 countries: United States, Belgium, Netherlands, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03525548. Inclusion in this directory is not an endorsement.