A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 vs Placebo as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Hepatitis C, Genotype 1 Infected Subjects Who Relapsed After Previous Interferon-based Therapy

Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 vs Placebo as Part of a Treatment Regimen Including Peginterferon Alfa-2a and Ribavirin in Hepatitis C, Genotype 1 Infected Subjects Who Relapsed After Previous Interferon-based Therapy

Completed
Phase of Trial: Phase III

Latest Information Update: 31 May 2017

At a glance

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

    • 07 Jun 2017 Biomarkers information updated
    • 13 Apr 2014 Subgroup analysis of European patients presented at the 49th Annual Meeting of the European Association for the Study of the Liver.
    • 24 Mar 2014 Results from an analysis of this trial will be presented at The International Liver Congress of the European Association for the study of the Liver (EASL) according to a Medivir AB media release.
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