A Phase 2a, Partly Randomized, Open-label Trial to Investigate the Efficacy and Safety of an 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Subjects With Chronic Genotype 4 Hepatitis C Infection

Trial Profile

A Phase 2a, Partly Randomized, Open-label Trial to Investigate the Efficacy and Safety of an 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Subjects With Chronic Genotype 4 Hepatitis C Infection

Completed
Phase of Trial: Phase II

Latest Information Update: 18 Jan 2018

At a glance

  • Drugs Simeprevir (Primary) ; Sofosbuvir
  • Indications Hepatitis C
  • Focus Therapeutic Use
  • Acronyms OSIRIS
  • Sponsors Janssen-Cilag
  • 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.
    • 26 Dec 2015 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov record.
    • 17 Nov 2015 Preliminary results of phase 2a part presented at The Liver Meeting 2015: 66th Annual Meeting of the American Association for the Study of Liver Diseases
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