Trials / Completed
CompletedNCT02128542
Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis
A Phase 4, Multicenter, Open Label Study to Investigate the Efficacy and Safety of an All Oral Combination of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis VALOR-HCV: Veterans Affairs alL Oral Regimen of SOF+RBV in GT2 HCV
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study will examine the safety, tolerability, and antiviral efficacy of sofosbuvir (SOF)+ribavirin (RBV) in treatment-naive and treatment-experienced United States Veterans with compensated cirrhosis and genotype 2 HCV infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Sofosbuvir | Sofosbuvir 400 mg tablet administered orally once daily |
| DRUG | RBV | Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) |
Timeline
- Start date
- 2014-06-01
- Primary completion
- 2015-06-01
- Completion
- 2015-06-01
- First posted
- 2014-05-01
- Last updated
- 2016-08-03
- Results posted
- 2016-08-03
Locations
17 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02128542. Inclusion in this directory is not an endorsement.