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
13
sites
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