NCT01435226

GS-5885, GS-9451, Tegobuvir and Ribovirin in Treatment-Experienced Subjects With Chronic Genotype 1a Or 1b Hepatitis C Virus (HCV) Infection

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared With GS-5885, GS-9451 With Tegobuvir or RBV in Treatment-Experienced Subjects With Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) Compared with GS-5885, GS-9451 with Tegobuvir or RBV in Treatment-Experienced Subjects with Chronic Genotype 1a or 1b Hepatitis C Virus (HCV) Infection.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	GS-5885	Drug: GS-5885 tablet GS-5885 tablet, 90 mg, QD
DRUG	GS-9451	Drug: GS-9451 tablet GS-9451 tablet, 200 mg QD
DRUG	tegobuvir	tegobuvir 30 mg BID
DRUG	placebo to match tegobuvir	tegobuvir placebo BID
DRUG	placebo to match RBV	Ribovirin placebo BID
DRUG	Ribavirin	Ribavirin (Copegus®) BID (1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg) divided BID

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-01-01
• Completion: 2013-07-01
• First posted: 2011-09-16
• Last updated: 2013-12-17

Locations

51 sites across 2 countries: United States, Germany