A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C

• Status: Completed
• Trial end date: 2014-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, double-blind, multi-center, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) (MCB) in combination with telaprevir (TVR) and peginterferon Alfa-2a (PEG-IFN) / ribavirin (RBV) in participants with chronic Hepatitis C infection.

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

Details

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

Criteria

Inclusion Criteria:

• Chronic hepatitis C infection for at least 6 months duration

• Hepatitis C genotype 1a or 1b

• Participants must have discontinued prior hepatitis C treatment at least 12 weeks prior to enrollment in this study

• Participants showed a previous null response to therapy as defined by < 2 logarithm to the base 10 (log10) international units per milliliter (IU/mL) decrease in viral titer after at least 12 weeks of treatment with PEG-IFN/RBV

Exclusion Criteria:

• Hepatitis C infection with a genotype other than genotype 1a or 1b

• Body mass index < 18 or >= 36 kilograms per square meters (kg/m^2)

• Hepatitis A, hepatitis B, or human immunodeficiency virus (HIV) infection

• Herbal remedies <=1 month prior to the first dose of study drug