An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients

Phase 3 Completed 457 enrolled Janssen R&D Ireland

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to provide confirmatory efficacy and safety data of TMC435 as part of a treatment regimen including peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV) in patients with genotype 1 Hepatitis C virus (HCV) infection.

Timeline

Start: 2012-11
Primary completion: 2014-08
Completion: 2014-11

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Simeprevir	Small molecule	100 mg	Oral
Subject	Simeprevir	Small molecule	150 mg	Oral
Background	Peginterferon Alpha	Unknown	180 ug	Subcutaneous
Background	Ribavirin	Small molecule	1000 mg	Oral
Background	Ribavirin	Small molecule	1200 mg	Oral

An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients

Summary

Timeline

Drugs

Indications