A Phase 3 Study to Assess the Efficacy and Safety of Boceprevir in Combination with Peginterferon alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1
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Last updated:14th Aug 2012
� To assess the efficacy of boceprevir used in combination with peginterferon alfa-2b (PEG2b) plus ribavirin (RBV) in non-cirrhotic, treatment na�ve pediatric subjects with chronic hepatitis C (CHC) genotype 1. � To evaluate the safety and tolerability of BOC/PR in pediatric subjects. � To assess in pediatric subjects who are non-cirrhotic, treatment failures or who are cirrhotics the proportion of subjects who achieve SVR when they are retreated with BOC/PR. � To evaluate the safety and tolerability of BOC/PR in pediatric subjects who are non-cirrhotic, treatment failures or who are cirrhotics. � To confirm the durability of the virologic response in the subjects who were sustained responders at 24 weeks posttreatment in Part A or Part B. � To characterize the long-term safety of boceprevir, including growth assessment and sexual maturation, in subjects who received treatment in Part A or Part B.
|Study start date||2012-08-14|