A Phase 3, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin Administered for 12 Weeks in Treatment-Naïve Subjects With Chronic Genotype 1 or Genotype 4 HCV Infection

Trial Profile

A Phase 3, Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of TMC435 Plus Pegylated Interferon Alfa-2a and Ribavirin Administered for 12 Weeks in Treatment-Naïve Subjects With Chronic Genotype 1 or Genotype 4 HCV Infection

Completed
Phase of Trial: Phase III

Latest Information Update: 17 Nov 2015

At a glance

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

    • 24 Sep 2015 Status changed from active, no longer recruiting to completed as per ClinicalTrials.gov record.
    • 16 Mar 2015 Results published in Results published in Medivir AB media release.
    • 12 Jan 2015 Planned End Date changed from 1 May 2015 to 1 Aug 2015 as per ClinicalTrials.gov record.
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