NCT00963885

A Study of RO5190591 (Danoprevir) in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Genotype 1 Virus Infection

A Randomized, Partially-blind Study on the Safety, Tolerability and Effect on Virological Response of Treatment With the HCV Protease Inhibitor RO5190591 in Combination With Pegasys and Copegus, Versus Pegasys and Copegus Alone, in Treatment-Naïve Patients With Hepatitis C Genotype 1 Virus Infectio

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This 2 part study will evaluate the efficacy and safety of 12 and 24 weeks treatment with RO5190591 (danoprevir) in combination with Pegasys and Copegus, compared to Pegasys and Copegus alone, in treatment-naive patients with chronic hepatitis C genotype 1 virus infection.In Part 1 of the study, patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours, 2) RO5190591 600mg po every 12 hours, 3) RO5190591 900mg po every 12 hours or 4) placebo, in combination with standard doses of Pegasys and Copegus. If the safety and virological response data from Part 1 of the study are supportive, in Part 2 patients will be randomized to receive either 1) RO5190591 300mg po every 8 hours or 600mg po every 12 hours or 900mg po every 12 hours or 2)placebo, in combination with standard doses of Pegasys and Copegus. The anticipated time on study treatment is 24-48 weeks, and the target sample size is 100-500 individuals.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Copegus	1000 or 1200mg po daily for 24 or 48 weeks
DRUG	Pegasys	180micrograms sc weekly for 24 or 48 weeks
DRUG	Placebo	po for 12 weeks
DRUG	Placebo	po for 24 weeks
DRUG	RO5190591 (Danoprevir)	300mg po q8h for 12 weeks
DRUG	RO5190591 (Danoprevir)	600mg po q12h for 12 weeks
DRUG	RO5190591 (Danoprevir)	900mg po q12h for 12 weeks
DRUG	RO5190591 (Danoprevir)	300mg po q8h or 600mg po q12h or 900po q12h for 24 weeks

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2009-08-24
• Last updated: 2016-11-02

Locations

43 sites across 7 countries: United States, Australia, Austria, Canada, France, Germany, Italy