Trials / Completed
CompletedNCT03118843
Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Adults Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects Who Participated in a Prior Gilead-Sponsored HCV Treatment Study
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SOF/VEL/VOX | 400/100/100 mg FDC tablet administered orally once daily with food |
Timeline
- Start date
- 2017-04-25
- Primary completion
- 2018-03-19
- Completion
- 2018-03-19
- First posted
- 2017-04-18
- Last updated
- 2019-04-03
- Results posted
- 2019-04-03
Locations
27 sites across 7 countries: United States, Australia, Canada, France, Germany, New Zealand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03118843. Inclusion in this directory is not an endorsement.