NCT01483742

A Study of Ritonavir-Boosted Danoprevir and RO5024048 in Different Combinations in Null Responder or Treatment-Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis

A Study to Evaluate Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Ritonavir-Boosted DANOPREVIR and RO5024048 in Different Combinations in Null Responder or Treatment Naïve Patients With Chronic Hepatitis C and Compensated Cirrhosis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This open-label, parallel cohort study will evaluate the safety, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and ribavirin in treatment-naïve patients, and with RO5024048 added to the combination treatment in prior null responder patients with chronic hepatitis C genotype 1 or 4 and compensated cirrhosis. All patients will receive danoprevir 100 mg orally twice daily (bid) , ritonavir 100 mg orally bid, Pegasys 180 mcg subcutaneously weekly and ribavirin 1000-1200 mg/kg/day orally. Prior non-responders will receive RO5024048 1000 mg orally bid additionally. Anticipated time on study treatment is 24 weeks.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	RO5024048	1000 mg orally bid, 24 weeks
DRUG	danoprevir	100 mg orally bid, 24 weeks
DRUG	peginterferon alfa-2a [Pegasys]	180 mcg weekly, 24 weeks
DRUG	ribavirin	1000-1200 mg/kg/day orally in two divided doses, 24 weeks
DRUG	ritonavir	100 mg orally bid, 24 weeks

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-09-01
• Completion: 2013-09-01
• First posted: 2011-12-01
• Last updated: 2016-08-01

Locations

27 sites across 7 countries: United States, Australia, Canada, France, New Zealand, Poland, Slovakia