NCT01434498

GS-5885, GS-9451, Tegobuvir and Ribavirin (RBV) in Interferon Ineligible or Intolerant 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; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects With Chronic Genotype 1a or 1b HCV Infection (Protocol No. GS US 248 0132)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 163 (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; GS-5885, GS-9451 and Tegobuvir; GS-5885, GS-9451 and Ribavirin in Interferon Ineligible or Intolerant Subjects with Chronic Genotype 1a or 1b HCV Infection.

Conditions

• Chronic Genotype 1a or 1b HCV Infection

Interventions

Type	Name	Description
DRUG	GS-5885 tablet	GS-5885 tablet, 90 mg, QD
DRUG	GS-9451 tablet	GS-9451 tablet, 200 mg QD
DRUG	tegobuvir capsule	tegobuvir capsule, 30 mg BID
DRUG	ribavirin tablet	ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
DRUG	placebo matching ribavirin tablet	placebo matching ribavirin tablet, BID
DEVICE	placebo matching tegobuvir capsule	placebo matching tegobuvir capsule, BID

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2011-09-15
• Last updated: 2013-12-20

Locations

50 sites across 3 countries: United States, Canada, Puerto Rico