143
Participants
Start Date
March 31, 2013
Primary Completion Date
April 30, 2015
Study Completion Date
April 30, 2015
Samatasvir
Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.
Simeprevir
Simeprevir will be supplied as 75 and 150 mg oral capsules.
Ribavirin (RBV)
Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.
TMC647055
TMC647055 will be supplied as 150 mg oral capsules.
Ritonavir (RTV)
Ritonavir will be supplied as 80 mg/mL oral solution.
Pegylated interferon (Peg-IFN)
Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.
Samatasvir matching placebo
Samatasvir matching placebo will be supplied for the 50 mg tablets used in Part A.
Janssen Research & Development, LLC
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY