NCT01625338

Open-Label Study of Sofusbuvir+Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

An Open-Label Study of GS-7977 + Ribavirin With or Without Peginterferon Alfa-2a in Subjects With Chronic HCV Infection Who Participated in Prior Gilead HCV Studies

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 534 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety, and tolerability of sofosbuvir (SOF; GS-7977) in combination with ribavirin (RBV) with or without pegylated interferon (Peg-IFN) in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead HCV study and have not achieved sustained virologic response (SVR).

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	SOF	SOF 400 mg tablet administered orally once daily
DRUG	RBV	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)
DRUG	Peg-IFN	Peg-IFN 180 μg administered once weekly by subcutaneous injection

Timeline

• Start date: 2012-06-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2012-06-21
• Last updated: 2015-11-09
• Results posted: 2015-11-09

Locations

175 sites across 16 countries: United States, Australia, Austria, Canada, Czechia, Estonia, France, Germany, Italy, Netherlands, New Zealand, Poland, Puerto Rico, Spain, Sweden, United Kingdom