NCT01278134

A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)

INFORM-SVR: A Randomized, Multi-Center Study of Interferon-Free Treatment With a Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir Boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) With or Without Copegus® in Interferon Naïve HCV Genotype 1 Infected Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up. As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	Copegus placebo	1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
DRUG	RO5024048	1000 mg bid orally, up to 24 weeks
DRUG	danoprevir	100 mg bid orally, up to 24 weeks
DRUG	peginterferon alfa-2a [Pegasys]	180 mcg sc weekly, 24 weeks
DRUG	ribavirin [Copegus]	1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
DRUG	ritonavir	100 mg bid orally, up to 24 weeks

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-10-01
• Completion: 2012-10-01
• First posted: 2011-01-17
• Last updated: 2016-11-02

Locations

32 sites across 4 countries: United States, France, Germany, New Zealand