A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients

Phase 2 Completed 92 enrolled Janssen Pharmaceutical K.K.

RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to evaluate effectiveness, safety and pharmacokinetics (Explores what the body does to the medication) of TMC435350 in combination with Peginterferon Alfa-2a and Ribavirin in genotype 1 hepatitis C virus infected Japanese participants who have never received treatment for their hepatitis C infection.

Timeline

Start: 2009-07
Primary completion: 2011-01
Completion: 2011-01

Publications

Hayashi N, Seto C, Kato M, Komada Y, Goto S. Once-daily simeprevir (TMC435) with peginterferon/ribavirin for treatment-naive hepatitis C genotype 1-infected patients in Japan: the DRAGON study. J Gastroenterol. 2014 Jan;49(1):138-47. doi: 10.1007/s00535-013-0875-1. Epub 2013 Sep 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Simeprevir	Small molecule	50 mg	Oral
Subject	Simeprevir	Small molecule	100 mg	Oral
Background	Peginterferon alfa-2a	Protein / enzyme biologic	180 ug	Subcutaneous
Background	RBV	Unknown	300 mg	Oral
Background	RBV	Unknown	400 mg	Oral
Background	RBV	Unknown	500 mg	Oral

A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients

Summary

Timeline

Publications

Drugs

Indications