NCT01749150

A Study of Ritonavir-Boosted Danoprevir in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients of Asian Origin With Chronic Hepatitis C Genotype 1 With or Without Cirrhosis

STUDY TO EVALUATE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND ANTIVIRAL ACTIVITY OF RITONAVIR-BOOSTED DANOPREVIR IN COMBINATION WITH PEGINTERFERON ALFA-2A PLUS RIBAVIRIN IN TREATMENT-NAÏVE PATIENTS OF ASIAN ORIGIN WHO HAVE CHRONIC HEPATITIS C GENOTYPE 1 WITH OR WITHOUT COMPENSATED CIRRHOSIS

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase II, open-label, parallel-arm study will evaluate the safety, tolerability, pharmacokinetics and antiviral activity of ritonavir-boosted danoprevir in combination with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in treatment-naïve patients of Asian origin with chronic hepatitis C genotype 1. Patients will receive danoprevir 125 mg plus ritonavir 100 mg as fixed dose tablet orally twice daily in combination with weekly Pegasys 180 mcg subcutaneously and Copegus 1000-1200 mg orally daily in divided doses. Treatment duration is 12 weeks in patients without cirrhosis and 24 weeks in patients with compensated cirrhosis.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	danoprevir + ritonavir	125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks
DRUG	danoprevir + ritonavir	125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 24 weeks
DRUG	peginterferon alfa-2a [Pegasys]	180 mcg sc weekly, 12 weeks
DRUG	peginterferon alfa-2a [Pegasys]	180 mcg sc weekly, 24 weeks
DRUG	ribavirin [Copegus]	1000-1200 mg orally daily in divided doses, 12 weeks
DRUG	ribavirin [Copegus]	1000-1200 mg orally daily in divided doses, 24 weeks

Timeline

• Start date: 2013-04-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2012-12-13
• Last updated: 2016-11-02

Locations

13 sites across 3 countries: South Korea, Taiwan, Thailand