A Phase II, Randomized, Double-Blind, Multicenter, Parallel Group Study to Evaluate the Sustained Virologic Response of the HCV Polymerase Inhibitor Prodrug RO5024048 in Combination With Boceprevir and Pegasys®/Copegus® in Patients With Chronic Hepatitis C Genotype 1 Virus Infection Who Were Prior Null Responders to Treatment With Pegylated Interferon/Ribavirin

NCT01482403 Phase 2 COMPLETED

This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.

Details

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	COMPLETED
Enrolment	58
Start date	2011-11
Completion	2014-01

Conditions

• Hepatitis C, Chronic

Interventions

• Copegus
• Copegus
• Pegasys
• Pegasys
• boceprevir
• boceprevir
• mericitabine
• mericitabine placebo
• boceprevir placebo
• boceprevir

Primary outcomes

• Sustained virological response 12 weeks after treatment (SVR-12) — up to 60 weeks

Countries

United States, Canada, France, Germany, Italy, Puerto Rico, Spain