Trials / Completed
CompletedNCT01713283
Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 Hepatitis C Virus (HCV) Infection
A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Sofosbuvir Plus Ribavirin Administered for Either 12 or 24 Weeks in Treatment-Naive and Treatment-Experienced Egyptian Adults With Chronic Genotype 4 HCV Infection
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is to evaluate the safety, tolerability, and antiviral activity of sofosbuvir (SOF) with ribavirin (RBV) in Egyptian adults with chronic genotype 4 hepatitis C virus (HCV) infection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SOF | Sofosbuvir (SOF) 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 (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2013-11-01
- Completion
- 2014-02-01
- First posted
- 2012-10-24
- Last updated
- 2014-11-25
- Results posted
- 2014-11-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01713283. Inclusion in this directory is not an endorsement.