Overview

A Study of Mericitabine in Combination With Boceprevir and Pegasys/Copegus in Patients With Chronic Hepatitis C

Status:
Completed

Trial end date:
2014-01-01

Target enrollment:
0

Participant gender:
All

Summary

This randomized, double-blind, multi-center, placebo-controlled, parallel-group study will evaluate the sustained virologic response and the safety of mericitabine (RO5024048) in combination with boceprevir and Pegasys/Copegus in patients with chronic hepatitis C infection. The anticipated time on study treatment is up to 48 weeks.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Hoffmann-La Roche

Treatments:

Interferon-alpha
Peginterferon alfa-2a
Ribavirin

Criteria

Inclusion Criteria:

- Adult patients, >/=18 years of age

- Chronic hepatitis C infection for at least 6 months duration

- Hepatitis C genotype 1a or 1b

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

- Patient showed a previous null response to therapy as defined by < 2 log10 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

- Hepatitis A, hepatitis B, or HIV infection

- Herbal remedies