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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Oct 2021

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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

  • 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.
  • 17 Mar 2014 Results from analyses, which included data from this trial, have been presented at the Conference of the Asian Pacific Association for the Study of the Liver (APASL). Results were also summarised in this Medivir AB media release.

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