A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

Trial Profile

A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Nov 2016

At a glance

  • Drugs Simeprevir (Primary) ; Sofosbuvir
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms PLUTO
  • Sponsors Janssen R&D Ireland
  • Most Recent Events

    • 29 Nov 2016 Results published in the Alimentary Pharmacology and Therapeutics.
    • 17 Apr 2016 Primary endpoint (Percentage of Subjects With Sustained Virologic Response (SVR 12) at Week 12 After End of Treatment (EOT)) has been met according to results presented at The International Liver Congress™ 2016.
    • 17 Apr 2016 Results presented at The International Liver Congress™ 2016.
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