drugset / Trial / NCT01425203

The Effect of Boceprevir in Russian Participants Diagnosed With Chronic Hepatitis C Genotype 1 (P08160)

NCT01425203

Phase 3 Completed 238 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2011-11-23
Primary completion
2013-10-21
Completion
2013-10-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Boceprevir Small molecule 800 mg Oral
Background Peginterferon alfa-2b Protein / enzyme biologic 1.5 ug/kg Subcutaneous
Background Ribavirin Small molecule 800 mg Oral
Background Ribavirin Small molecule 1400 mg Oral