drugset
drugset / Trial / NCT01288209

A Phase III Study of TMC435 in Genotype 1, Hepatitis C-infected Participants Who Failed to Respond to Previous IFN-based Therapy

NCT01288209 ↗

Phase 3 Completed 106 enrolled Janssen Pharmaceutical K.K.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus (HCV)-infected participants who failed to respond to previous interferon (IFN)-based therapy in Japan.

Timeline

Start
2011-02
Primary completion
2012-09
Completion
2012-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Simeprevir Small molecule 100 mg Oral
Background Peginterferon alfa-2a Protein / enzyme biologic 180 ug Subcutaneous
Background Ribavirin Small molecule 200 mg Oral
Background Ribavirin Small molecule 400 mg Oral
Background Ribavirin Small molecule 600 mg Oral

Indications

chronic hepatitis C virus infection