A Study of Danoprevir Boosted With Low Dose Ritonavir in Combination With Pegasys and Copegus in Treatment-Naive Patients With Chronic Hepatitis C Virus Infection

Phase 2

Completed

• Conditions: Hepatitis C, Chronic
• Interventions: Drug: Copegus; Drug: Pegasys; Drug: Danoprevir; Drug: Ritonavir

• Registration Number: NCT01220947
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This randomized, open-label, active-controlled, parallel-group study will evaluate the sustained virological response of danoprevir boosted with low dose ritonavir in combination with Pegasys (peginterferon alfa-2a) and Copegus versus Pegasys and Copegus alone in treatment-naive patients with chronic Hepatitis C.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Study Start: 2010-11
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Disposition First Submitted: 2016-07-08
• Disposition First Submitted QC: 2016-07-08
• Disposition First Posted: 2016-07-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 421

Inclusion Criteria

• Adults patients, >/=18 years of age
• Chronic Hepatitis C, Genotype 1 and 4
• HCV RNA >/=50,000 IU/mL
• treatment-naive

Exclusion Criteria

• Patients with cirrhosis or incomplete/transition to cirrhosis
• Patients with other forms of liver disease, HIV infection, hepatocellular carcinoma or severe cardiac disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group E	Copegus	Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 48 weeks
Group E	Pegasys	Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 48 weeks
Group A	Danoprevir	Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Group B	Pegasys	Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Group A	Pegasys	Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Group D	Pegasys	Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks
Group A	Copegus	Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Group B	Copegus	Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Group C	Copegus	Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Group C	Pegasys	Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Group D	Copegus	Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks
Group D	Danoprevir	Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks
Group A	Ritonavir	Danoprevir 200 mg twice a day (BID) + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Group B	Danoprevir	Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Group B	Ritonavir	Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Group C	Danoprevir	Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Group C	Ritonavir	Danoprevir 50 mg BID + ritonavir 100 mg + Pegasys 180 microgram sc qw + Copegus 1000 mg or 1200 mg po daily for 24 weeks
Group D	Ritonavir	Danoprevir 100 mg BID + ritonavir 100 mg + Pegasys 180 μg sc qw + Copegus 1000 mg or 1200 mg po daily for 12 weeks or 24 weeks

Primary Outcome Measures

Name	Time	Method
Sustained virological response (HCV RNA measured by Roche COBAS TaqMan HCV test)	24 weeks after end of treatment

Secondary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	from baseline up to 72 weeks
Evaluation of relapse rate	up to 24 weeks after end of treatment
Characterization of resistance profile (HCV RNA sequencing and/or phenotypic analyses)	from baseline up to 72 weeks
Virological response at scheduled visits over time (HCV RNA measured by Roche COBAS TaqMan HCV test)	From baseline up to 72 weeks
Evaluation of virological breakthrough (viral load rebound) rate	up to 72 weeks
Evaluation of pharmacokinetics (serum concentrations assessed by validated methods)	up to 72 weeks