Status:
COMPLETED
A Study of Mericitabine in Combination With Telaprevir and Peginterferon Alfa-2a / Ribavirin in Participants With Chronic Hepatitis C
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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) a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2014
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01482390
Start Date
November 30 2011
End Date
January 31 2014
Last Update
April 24 2017
Active Locations (39)
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1
Birmingham Gastro Associates, P.C.
Birmingham, Alabama, United States, 35209
2
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
3
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States, 95825
4
UCSD Antiviral Research Center
San Diego, California, United States, 92103