A Study of Danoprevir/Ritonavir and Copegus With RO5024048 and/or Pegasys in Patients With Chronic Hepatitis C

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, open-label, multi-center study will evaluate the sustained virological response, pharmacokinetics and safety of various combinations of danoprevir/ritonavir with Copegus plus RO5024048 and/or Pegasys in patients with chronic hepatitis C infection. Patients will be divided into 2 separate cohorts. Cohort A, previous partial responders, will be randomized to Groups 1-3 and cohort B, previous null responders, will be randomized to Groups 4-6. Patients in all groups will receive danoprevir 100 mg twice a day and ritonavir 100 mg twice a day for 24 weeks. In addition, Groups 1 and 4 will receive RO5024048 1000 mg twice a day and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Group 2 will receive Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks; Groups 3, 5 and 6 will receive RO5024048 1000 mg twice a day, Pegasys 180 microgram subcutaneously once weekly and Copegus 1000 mg or 1200 mg twice a day for 24 weeks. In addition, patients in Group 6 will receive another 24 weeks of Pegasys plus Copegus treatment.

• 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:

• Adult patients, age 18 years and older

• Presence of hepatitis C infection, genotype 1a or 1b

• Documentation of previous treatment failure after receiving approved doses of peginterferon plus ribavirin for at least 12 weeks

• Patients must have discontinued prior hepatitis C treatment at least 12 weeks prior to study start

Exclusion Criteria:

• Infection with any hepatitis C genotype or subtype other than genotype 1a or 1b

• Patients with cirrhosis

• Patients who were discontinued from previous peginterferon plus ribavirin therapy due to reasons other than insufficient therapeutic response

• Co-infection with hepatitis B or human immunodeficiency virus (HIV)

• History or evidence of chronic liver disease other than hepatitis C