A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability 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 Study to Investigate the Efficacy, Pharmacokinetics, Safety and Tolerability 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: 18 Jan 2016

At a glance

  • Drugs Simeprevir (Primary) ; Peginterferon alfa-2a; Ribavirin
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Sponsors Janssen R&D Ireland
  • Most Recent Events

    • 18 Jan 2016 Results published in the Journal of Gastroenterology and Hepatology
    • 18 Jan 2016 Primary endpoint (SVR12) has been met as results published in the Journal of Gastroenterology and Hepatology.
    • 16 Mar 2015 Results published in Medivir AB media release.
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