Safety and Efficacy of Boceprevir in Asia Pacific Participants With Chronic Hepatitis C Genotype 1 (P07063)
Status:
Completed
Trial end date:
2015-06-19
Target enrollment:
Participant gender:
Summary
This study will assess the efficacy of boceprevir (BOC) in combination with PegIntron
(pegylated interferon alfa-2b) (PEG) and ribavirin (RBV) in response guided therapy compared
to the efficacy of standard-of-care therapy alone in adult subjects with chronic hepatitis C
(CHC) genotype 1 who failed prior treatment with pegylated interferon and RBV in the Asia
Pacific population. The primary hypothesis is that the proportion of participants achieving
sustained virologic response in the experimental therapy regimen (BOC/PEG+RBV) is superior to
that in the control arm (Placebo/PEG+RBV), in the Full Analysis Set (FAS) population.