drugset
drugset / Trial / NCT01290731

A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy

NCT01290731 ↗

Phase 3 Completed 49 enrolled Janssen Pharmaceutical K.K.
NaSingle-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 relapsed after previous interferon (IFN)-based therapy in Japan.

Timeline

Start
2011-01
Primary completion
2012-08
Completion
2012-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Simeprevir Small molecule 100 mg Oral
Background PegIFN-alpha-2a Protein / enzyme biologic 180 ug Subcutaneous
Background Ribavirin Small molecule 200 mg Oral

Indications

chronic hepatitis C virus infection