NCT01225380

A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® 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 Response Guided Therapy With GS-9190, GS-9256, Ribavirin (Copegus®) and Peginterferon Alfa 2a (Pegasys®) in Treatment Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection (Protocol No. GS-US-196-0123)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 324 (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 response-guided duration of therapy with GS-9190 and GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) will be evaluated.

Conditions

• Chronic Hepatitis C Infection

Interventions

Type	Name	Description
DRUG	GS-9190	GS-9190 capsule, 20 mg BID, 16 or 24 weeks
DRUG	GS-9256	GS-9256 capsule, 150 mg BID, 16 or 24 weeks
BIOLOGICAL	Pegasys®	peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks
DRUG	Copegus®	ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks
DRUG	GS-9190 placebo	placebo matching GS-9190 capsule BID, 24 weeks
DRUG	GS-9256	GS-9256 capsule, 150 mg BID, 24 weeks
BIOLOGICAL	Pegasys®	peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks
DRUG	Copegus®	ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), up to 48 weeks
DRUG	GS-9190 placebo	placebo matching GS-9190 capsule BID, 24 weeks
DRUG	GS-9256 placebo	placebo matching GS-9256 capsule BID, 24 weeks
BIOLOGICAL	Pegasys®	peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks
DRUG	Copegus®	ribavirin 200 mg tablet (weight based: 1000 mg/day \<75 kg; 1200 mg/day \>/= 75 kg) divided twice daily (BID), 48 weeks

Timeline

• Start date: 2010-10-01
• Primary completion: 2013-01-01
• Completion: 2013-09-01
• First posted: 2010-10-21
• Last updated: 2014-01-28

Locations

114 sites across 11 countries: United States, Austria, Belgium, Canada, Czechia, France, Germany, Italy, Poland, Spain, United Kingdom