Trials / Completed
CompletedNCT02996682
Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Adults With Chronic HCV Infection and Decompensated Cirrhosis
A Multicenter, Randomized, Phase 3, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir ± Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Decompensated Cirrhosis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 102 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) with or without ribavirin (RBV) for 12 weeks in adults with chronic hepatitis C virus (HCV) infection and decompensated cirrhosis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SOF/VEL | 400/100 mg FDC tablet administered orally once daily |
| DRUG | RBV | Capsules administered orally in a divided daily dose |
Timeline
- Start date
- 2016-12-26
- Primary completion
- 2018-02-13
- Completion
- 2018-05-08
- First posted
- 2016-12-19
- Last updated
- 2019-02-26
- Results posted
- 2019-02-26
Locations
33 sites across 1 country: Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02996682. Inclusion in this directory is not an endorsement.