A Randomized, Open label, Multicenter, Dose and Duration Finding Study to Evaluate the Sustained Virologic Response of the HCV Protease Inhibitor Danoprevir (RO5190591) Boosted with Low Dose Ritonavir (danoprevir/r) in Combination with Pegasys and Copegus versus Pegasys and Copegus alone in Treatment-Naive Patients with Chronic Hepatitis C Genotype 1 or 4 Virus Infection - DAUPHINE

• Conditions: Chronic Hepatitis C; MedDRA version: 9.1Level: LLTClassification code 10008912

• Registration Number: EUCTR2010-019584-10-IT
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-24
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 405

Inclusion Criteria

- Adults patients, >/=18 years of age - Chronic Hepatitis C, Genotype 1 and 4 - HCV RNA >/=50,000 IU/mL - treatment-naive
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To study the effects of different doses and durations of danoprevir/r treatment in combination with Pegasys and Copegus on the proportion of patients who achieve sustained virological response versus the currently approved combination of Pegasys and Copegus in treatment-naive patients with chronic hepatitis C genotype 1 or 4 virus infection.;Secondary Objective: - To evaluate the safety and tolerability of danoprevir/r in combination with Pegasys + Copegus versus Pegasys + Copegus alone. - To determine virologic response at scheduled visits over time. - To evaluate relapse rate. - To evaluate virological breakthrough (viral load rebound)rate. - To characterize the resistance. profile of RO5190591 when given in combination with Pegasys + Copegus. - To evaluate the pharmacokinetics of danoprevir/r when given in combination with Pegasys + Copegus.;Primary end point(s): Sustained virological response 24 weeks after end of treatment.