A Phase III, Randomized, Double-blind, Placebo-controlled Trial in Japan to Investigate the Efficacy and Safety of TMC435 vs. Placebo as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Treatment-Naive, Genotype 1, Hepatitis C-infected Subjects.

Trial Profile

A Phase III, Randomized, Double-blind, Placebo-controlled Trial in Japan to Investigate the Efficacy and Safety of TMC435 vs. Placebo as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Treatment-Naive, Genotype 1, Hepatitis C-infected Subjects.

Completed
Phase of Trial: Phase III

Latest Information Update: 09 Apr 2014

At a glance

  • Drugs Simeprevir (Primary) ; Peginterferon alfa-2a; Ribavirin
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms CONCERTO-1
  • Sponsors Janssen Pharmaceutical KK
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 09 Apr 2014 Results published in the Journal of Hepatology.
    • 06 Jun 2013 Results published in a Medivir AB media release and presented at the Japan Society of Hepatology's 49th Annual Meeting.
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