A Phase III, Open-label Trial in Japan to Investigate the Efficacy and Safety of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Genotype 1, Hepatitis C-infected Subjects Who Relapsed After Previous IFN-based Therapy.

Trial Profile

A Phase III, Open-label Trial in Japan to Investigate the Efficacy and Safety of TMC435 as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Genotype 1, Hepatitis C-infected Subjects Who Relapsed After Previous IFN-based Therapy.

Completed
Phase of Trial: Phase III

Latest Information Update: 01 May 2014

At a glance

  • Drugs Simeprevir (Primary) ; Peginterferon alfa-2a; Ribavirin
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms CONCERTO-3
  • Sponsors Janssen Pharmaceutical KK
  • Most Recent Events

    • 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.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top