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

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Interferon-alpha; Lactams; Peginterferon alfa-2a; Ribavirin; Ritonavir

Criteria

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