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-Naïve or -Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and Cirrhosis

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-Naïve or -Experienced Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and Cirrhosis

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Dec 2015

At a glance

  • Drugs Simeprevir (Primary) ; Sofosbuvir (Primary)
  • Indications Hepatitis C
  • Focus Registrational; Therapeutic Use
  • Acronyms OPTIMIST-2
  • Sponsors Janssen R&D Ireland
  • Most Recent Events

    • 24 Dec 2015 Results published in the Hepatology
    • 24 Jul 2015 According to a Medivir AB media release, Janssen has submitted a sNDA to the U.S.FDA to update the label for once-daily, all-oral OLYSIO (simeprevir), based on the results of this and OPTIMIST-1 trial.
    • 23 Jul 2015 Results published in Janssen Therapeutics media release.
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