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

Recruiting in Palo Alto (17 mi)

+143 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Gilead Sciences

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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®).

Eligibility Criteria

Inclusion Criteria

Adult subjects 18 to 70 years of age

Chronic HCV infection for at least 6 months prior to Baseline (Day 1)

Liver biopsy results (performed no more than 2 years prior to Screening) indicating the absence of cirrhosis

See 6 more

Treatment Details

Interventions

Copegus® (Nucleoside Analog)
GS-9451 (Protease Inhibitor)
Pegasys® (Interferon)
Tegobuvir (GS-9190) (Nucleoside Analog)

Participant Groups

3Treatment groups

Active Control

Placebo Group

Group I: Arm 2Active Control4 Interventions

GS-9451 (active) and Tegobuvir (GS-9190) placebo in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy

Group II: Arm 1Active Control4 Interventions

GS-9451 and Tegobuvir (GS-9190) in combination with Pegasys® and Copegus® for 16 or 24 weeks; Pegasys® and Copegus® may be continued for up to 48 weeks total duration depending on individual response to therapy

Group III: Arm 3Placebo Group4 Interventions

Placebo matching Tegobuvir (GS-9190) and GS-9451 in combination with Pegasys® and Copegus® for 24 weeks; Pegasys® and Copegus® will be continued for up to 48 weeks total duration