A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 Versus Placebo as Part of a Treatment Regimen Including Peginterferon α-2a (Pegasys) and Ribavirin (Copegus) or Peginterferon α-2b (PegIntron) and Ribavirin (Rebetol) in Treatment-naïve, Genotype 1, Hepatitis C-infected Subjects

Trial Profile

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety and Tolerability of TMC435 Versus Placebo as Part of a Treatment Regimen Including Peginterferon α-2a (Pegasys) and Ribavirin (Copegus) or Peginterferon α-2b (PegIntron) and Ribavirin (Rebetol) in Treatment-naïve, Genotype 1, Hepatitis C-infected Subjects

Completed
Phase of Trial: Phase III

Latest Information Update: 31 May 2017

At a glance

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

    • 07 Jun 2017 Biomarkers information updated
    • 09 Apr 2015 According to a Janssen Sciences media release, a multivariate analysis of this study will be presented at the European Associate for the Study of the Liver (EASL) 2015.
    • 10 Oct 2014 A post-hoc analysis of pooled efficacy data from QUEST 1 and 2 was presented at the Viral Hepatitis Congress (VHC).
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