NCT01482403

A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Copegus	total daily dose of 1000 mg or 1200 mg for 24 weeks
DRUG	Copegus	total daily dose of 1000 mg or 1200 mg for 48 weeks
DRUG	Pegasys	180 microgram subcutaneous once a week for 24 weeks
DRUG	Pegasys	180 microgram subcutaneous once a week for 48 weeks
DRUG	boceprevir	800 mg three times a day for 24 weeks
DRUG	boceprevir	800 mg three times a day for 48 weeks
DRUG	mericitabine	1000 mg twice daily for 24 weeks
DRUG	mericitabine placebo	mericitabine placebo
DRUG	boceprevir placebo	boceprevir placebo
DRUG	boceprevir	800 mg three times a day for 44 weeks

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-11-30
• Last updated: 2016-08-05

Locations

24 sites across 7 countries: United States, Canada, France, Germany, Italy, Puerto Rico, Spain