NCT01682720

Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of GS-7977+Ribavirin for 12 Weeks in Treatment Naive and Treatment Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 421 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	SOF	Sofosbuvir (SOF) 400 mg tablet administered orally once daily
DRUG	RBV	Ribavirin (RBV) 200 mg 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	Placebo to match SOF	Placebo to match SOF administered orally once daily
DRUG	Placebo to match RBV	Placebo to match RBV administered orally in a divided daily dose

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-10-01
• Completion: 2014-01-01
• First posted: 2012-09-11
• Last updated: 2014-10-09
• Results posted: 2014-10-09

Locations

77 sites across 10 countries: Austria, Estonia, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, United Kingdom