NCT01271790

A Study of Response-Guided Duration of Combination Therapy With GS-9451, Pegasys® and Copegus® With and Without Tegobuvir (GS-9190) in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating 16 and 24 Weeks of Four-Drug Regimen and 24 Weeks of a Three-Drug Regimen of GS-9451, Peginterferon Alfa 2a (PEG, Pegasys®) and Ribavirin (RBV, Copegus®) With and Without Tegobuvir (GS-9190) Followed by Response Guided PEG and RBV in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS US 196 0140

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of a 4-drug regimen with GS-9451 and Tegobuvir and 24 weeks of a 3-drug regimen of GS-9451 without Tegobuvir, all with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Tegobuvir (GS-9190)	Tegobuvir (GS-9190) capsule, 30 mg BID
DRUG	GS-9451	GS-9451 tablet, 200 mg once daily (QD)
BIOLOGICAL	Pegasys®	peginterferon alfa-2a (solution for injection) 180 µg/week
DRUG	Copegus®	ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
DRUG	GS-9451	GS-9451 tablet, 200 mg QD
DRUG	Tegobuvir placebo	placebo matching Tegobuvir (GS-9190) capsule BID
BIOLOGICAL	Pegasys®	peginterferon alfa-2a (solution for injection) 180 µg/week
DRUG	Copegus®	ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
DRUG	Tegobuvir placebo	placebo matching Tegobuvir (GS-9190) capsule BID
DRUG	GS-9451 placebo	placebo matching GS-9451 tablet QD
BIOLOGICAL	Pegasys®	peginterferon alfa-2a (solution for injection) 180 µg/week
DRUG	Copegus®	ribavirin tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-01-01
• Completion: 2013-09-01
• First posted: 2011-01-07
• Last updated: 2014-02-06

Locations

144 sites across 8 countries: United States, Austria, Belgium, France, Germany, Netherlands, Poland, United Kingdom