Trials / Completed
CompletedNCT02607735
Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy
A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 416 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C virus (HCV) infection who have previously received treatment with direct-acting antiviral therapy. Participants randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SOF/VEL/VOX | 400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food |
| DRUG | Placebo | Tablet administered orally once daily with food |
Timeline
- Start date
- 2015-11-11
- Primary completion
- 2016-10-10
- Completion
- 2017-06-21
- First posted
- 2015-11-18
- Last updated
- 2019-03-05
- Results posted
- 2017-12-13
Locations
86 sites across 8 countries: United States, Australia, Canada, France, Germany, New Zealand, Puerto Rico, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02607735. Inclusion in this directory is not an endorsement.