drugset / Trial / NCT01756079

A Study to Evaluate the Efficacy and Safety of Boceprevir Added to Standard of Care Therapy in Previously Treated Participants With Chronic Hepatitis C Genotype 1 and Cirrhosis (MK-3034-105)

NCT01756079

Phase 4 Completed 58 enrolled Merck Sharp & Dohme LLC
NaSingle-groupOpen-labelTreatment

Summary

This study is being done to find out if the addition of boceprevir to standard of care (SOC) treatment with peginterferon alfa-2b (PegIFN-2b) + ribavirin (RBV) is effective for participants with chronic hepatitis C (CHC) genotype 1 and cirrhosis who were not successfully treated by previous SOC. All participants will receive treatment with SOC alone for 4 weeks and then boceprevir will be added to the treatment regimen for 44 additional weeks of combined treatment.

Timeline

Start
2013-02-06
Primary completion
2015-11-17
Completion
2015-11-17

Drugs

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