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

Phase 2

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: danoprevir + ritonavir; Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]

• Registration Number: NCT01749150
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2012-12-11
• Study First Posted: 2012-12-13
• Study Start: 2013-04
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• Adult patients of East Asian or Southeast Asian origin, >/= 18 years of age
• Presence of chronic genotype 1 hepatitis C infection
• Treatment-naïve

Exclusion Criteria

• History or presence of decompensated liver disease
• Presence or history of non-hepatitis C chronic liver disease
• Positive for hepatitis B or HIV infection

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with cirrhosis	peginterferon alfa-2a [Pegasys]	-
without cirrhosis	peginterferon alfa-2a [Pegasys]	-
without cirrhosis	ribavirin [Copegus]	-
with cirrhosis	ribavirin [Copegus]	-
with cirrhosis	danoprevir + ritonavir	-
without cirrhosis	danoprevir + ritonavir	-

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	approximately 1.5 years
Antiviral activity: Change in HCV RNA levels, measured using Roche COBAS TaqMan HCV Test v2.0 for High Pure System	from baseline to Week 36/48
Antiviral activity: Proportion of patients with unquantifiable/undetectable HCV RNA during the study	approximately 1.5 years
Pharmacokinetics: Area under the concentration-time curve (AUC) for danoprevir/ritonavir	up to 14 days

Secondary Outcome Measures

Name	Time	Method
Rapid virological response (RVR): Proportion of patients with undetectable HCV RNA at Week 4	approximately 1.5 years
Complete early virological response (cEVR): Proportion of patients with undetectable HCV RNA at Week 12	approximately 1.5 years
Sustained virological response 12 weeks after end of treatment (SVR-12), defined as unquantifiable HCV RNA 8-20 weeks after the last day of study drug administration	approximately 1.5 years
Sustained virological response 24 weeks after end of treatment (SVR-24), defined as unquantifiable HCV RNA > 20 weeks after the last day of study drug administration	approximately 1.5 years
SVR measured as HCV RNA log10 IU/mL change from baseline to Week 12	approximately 1.5 years
Incidence of viral resistance to danoprevir	approximately 1.5 years