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 Infectio

Phase 1

• Conditions: Chronic Hepatitis C; MedDRA version: 12.1Level: LLTClassification code 10008912Term: Chronic hepatitis C

• Registration Number: EUCTR2010-019584-10-FR
• Lead Sponsor: F.Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-06
• Study Completion: 2013-01-16
• Last Update Posted: 13 December 2021

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 <br>- To determine virologic response at scheduled visits over time<br>- To evaluate relapse rate.<br>- To evaluate virological breakthrough (viral load rebound) rate.<br>- To characterize the resistance profile <br>- To evaluate the pharmacokinetics of danoprevir/r when given in combination with Pegasys and Copegus;Primary end point(s): - Sustained virological response 24 weeks after end of treatment<br><br>