A Phase III, Open-Label Study in Japan to Assess the Efficacy and Safety of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2b and Ribavirin in Hepatitis C, Genotype 1 Infected Subjects.
Phase of Trial: Phase III
Latest Information Update: 01 May 2015
At a glance
- Drugs Simeprevir (Primary) ; Peginterferon alfa-2b; Ribavirin
- Indications Hepatitis C
- Focus Adverse reactions; Pharmacokinetics; Registrational; Therapeutic Use
- Acronyms CONCERTO-4
- Sponsors Janssen Pharmaceutical KK
- 07 Jun 2017 Biomarkers information updated
- 06 Jun 2013 Data published in a Medivir AB media release and presented at the Japan Society of Hepatology's 49th Annual Meeting.
- 22 Feb 2013 Data from this trial will be used in support of regulatory filings with the Japanese authorities for the use of simeprevir + peginterferon alfa + ribavirin for genotype 1 hepatitis C according to a a Medivir AB media release.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History