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

Status:	Completed
Conditions:	Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	10/19/2013
Start Date:	December 2011
End Date:	February 2014
Contact:	Reference Study ID Number: NV27779 www.roche.com/about_roche/roche_worldwide.htm
Email:	global.rochegenentechtrials@roche.com
Phone:	888-662-6728 (U.S. Only)

A PHASE II, RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PARALLEL GROUP STUDY TO EVALUATE THE SUSTAINED VIROLOGIC RESPONSE OF THE HCV POLYMERASE INHIBITOR PRODRUG RO5024048 IN COMBINATION WITH TELAPREVIR AND PEGASYS®/COPEGUS® IN PATIENTS WITH CHRONIC HEPATITIS C GENOTYPE 1 VIRUS INFECTION WHO WERE PRIOR NULL RESPONDERS TO TREATMENT WITH PEGYLATED INTERFERON/RIBAVIRIN

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

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

- Patients 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

We found this trial at

sites

Clinical Trial Facility in Baltimore Maryland

Baltimore, Maryland

from

Baltimore, MD