NCT01808248

Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3

A Phase 2, Open-Label Study of Sofosbuvir in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (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 efficacy of sofosbuvir (SOF) in combination with peginterferon alfa 2a (PEG) and ribavirin (RBV) administered for 12 weeks in participants with chronic genotype 2 or 3 hepatitis C virus (HCV) infection who have previously failed prior treatment with an interferon-based regimen.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	SOF	Sofosbuvir (SOF) 400 mg tablet administered orally once daily
DRUG	PEG	Peginterferon alfa 2a (PEG) 180 μg administered once weekly by subcutaneous injection
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: 2013-02-01
• Primary completion: 2013-09-01
• Completion: 2013-12-01
• First posted: 2013-03-11
• Last updated: 2014-09-12
• Results posted: 2014-09-12

Locations

1 site across 1 country: United States