drugset / Trial / NCT01945294

Short Duration Versus Standard Response-Guided Therapy With Boceprevir Combined With PegIntron and Ribavirin in Previously Untreated Non-Cirrhotic Asian Participants With Chronic HCV Genotype 1 (MK-3034-107)

NCT01945294

Phase 3 Completed 257 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to estimate the difference in the efficacy between a 16-week treatment regimen of boceprevir (BOC) in combination with peg-intron alpha 2b (P) plus ribavirin (R) (BOC + PR) and a 28-week treatment regimen of BOC + PR in previously untreated participants with chronic hepatitis C (CHC) genotype 1 in Asia who achieve undetectable hepatitis C virus ribonucleic acid (HCV RNA).

Timeline

Start
2013-10-10
Primary completion
2015-08-05
Completion
2015-11-04

Drugs

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