Chronic Hepatitis C Clinical Trial
Official title:
A Randomized, Phase 2a, Partially-Blind, Dose-Ranging Study to Evaluate the Safety, Pharmacokinetics and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
The purpose of the study is to determine the safety, pharmacokinetics and efficacy of orally administered VX-135 with ribavirin in treatment naive subjects with chronic hepatitis C infection.
Up to twenty (20) subjects with CHC GT1 infection will be randomized in a 1:1 ratio (with
stratification by IL-28B genotype (CC versus non-CC)) to evaluate VX-135 low dose or high
dose both given in combination with RBV for 12 weeks.
Safety and tolerability will be evaluated on an ongoing basis through assessment of adverse
events (AEs), lab evaluations and physical examinations. Subjects will be monitored from Day
1 through end of follow-up for virologic breakthrough or relapse.
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