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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 α-2a and Ribavirin in Treatment-naïve, Genotype 1 Hepatitis C infected Subjects

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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 α-2a and Ribavirin in Treatment-naïve, Genotype 1 Hepatitis C infected Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 08 Oct 2021

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At a glance

  • Drugs Simeprevir (Primary) ; Peginterferon alfa-2a; Ribavirin
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms QUEST-1
  • Sponsors Janssen R&D Ireland

Most Recent Events

  • 14 Jul 2019 Trial has been completed in UK, according to European Clinical Trials Database record.
  • 20 May 2015 Results of pooled data from ADVANCE, QUEST 1 and 2 trials comparing efficacy of simeprevir and telaprevir presented at the 20th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research.
  • 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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