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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jan 2018

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At a glance

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

    • Most Recent Events

    • 18 Jan 2018 Results of pooled post-hoc analysis assessing impact of pharmacokinetic interaction between simeprevir and concomitant medications by using data from nine studies (SONET, OPTIMIST-1, OPTIMIST-2, COMMIT, GALAXY, OSIRIS, IMPACT, PLUTO and SATURN) published in the British Journal of Clinical Pharmacology.
    • 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.

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