NCT01185860

A Study of Ritonavir-Boosted Danoprevir (RO5190591) in Combination With Pegasys and Ribavirin in Patients With Chronic Hepatitis C Genotype 1

A Multiple-Dose Study To Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted RO5190591 in Combination With Peginterferon Alfa-2a Plus Ribavirin in Patients With Chronic Hepatitis C Genotype 1

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety and tolerability of danoprevir (RO5190591) plus ritonavir as compared to danoprevir alone or placebo plus ritonavir in patients with chronic hepatitis C genotype 1 receiving Pegasys (peginterferon alfa-2a) and ribavirin. Patients in cohorts will be randomized to receive either oral doses of danoprevir, or danoprevir plus ritonavir, or placebo plus ritonavir. All patients will receive Pegasys (180mcg sc once weekly) plus ribavirin (1000-1200mg/day po), with the option to continue this treatment after completion of study drug treatment. Anticipated time on study treatment is up to 12 weeks.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	danoprevir	oral doses
DRUG	peginterferon alfa-2a [Pegasys]	180 mcg sc once weekly
DRUG	placebo	oral doses
DRUG	ribavirin	1000-1200mg/day po
DRUG	ritonavir	oral doses

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2010-08-20
• Last updated: 2016-11-02

Locations

4 sites across 3 countries: France, New Zealand, Poland