Conditions: Chronic Hepatitis C Genotype 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 238
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine whether Boceprevir (BOC, SCH 503034, MK-3034) in combination with Peginterferon Alfa 2-b (PEG) plus Ribavirin (RBV) \[PEG+RBV=PR\] is effective in the treatment of chronic hepatitis C (CHC) genotype 1 among the Russian population. The primary hypothesis is that the percentage of participants achieving sustained virologic response in the BOC + PR group is superior to that in the Placebo (PBO) + PR group.

Detailed description:

Arms:
arm 1: Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks. arm 2: Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks. arm 3: Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR.

Interventions: intervention 1: Boceprevir intervention 2: Placebo intervention 3: peginterferon alfa-2b intervention 4: Ribavirin
Intervention descriptions: intervention 1: boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO) intervention 2: boceprevir-matched placebo four 200-mg capsules PO TID. intervention 3: peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC) intervention 4: ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).

Protocol document: