The purpose of this study is to determine whether 24 week treatment with the Daclatasvir (DCV) in combination with Pegylated-interferon alfa 2a (pegIFNα-2a) and Ribavirin (RBV) is safe and demonstrates rate of Sustained Virologic Response at follow up week 24 (SVR24) (defined as undetectable HCV RNA at post-treatment Week 24) that are non-inferior to 48 weeks of the dual combination therapy of pegIFNα-2a/RBV in a majority of study subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Proportion of Genotype 1 subjects with SVR24, defined as HCV RNA < Limit of quantification (LOQ) at follow-up Week 24 for each cohort
Time frame: Week 24 post treatment follow up
Proportion of Genotype (GT) 4 subjects with SVR24
Time frame: Week 24 post treatment follow up visit
Proportion of GT 1 & 4 subjects who achieve HCV RNA < LOQ or undetectable
Time frame: Week 24 post treatment follow up visit and Week 48 post treatment follow up visit for subjects who achieve Virologic response [VR] (4&12)
Frequency of Serious Adverse Events (SAEs)/discontinuations due to Adverse Events (AEs)
Time frame: Up to 48 weeks plus 30 days
Discontinuations due to Adverse Events (AEs)
Time frame: Up to 48 weeks plus 7 days
Proportion of subjects with Sustained Virologic Response at follow up week 12 (SVR12) or SVR24 by rs12979860 Single nucleotide polymorphism (SNP) in the IL28B gene
Time frame: Up to 72 weeks
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