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: 29 Jan 2016

At a glance

  • Drugs Simeprevir (Primary) ; Sofosbuvir
  • Indications Hepatitis C
  • Focus Therapeutic Use
  • Acronyms OSIRIS
  • Sponsors Janssen-Cilag
  • Most Recent Events

    • 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
    • 16 Nov 2015 According to a Janssen-Cilag media release, preliminary results of this study were presented at Annual Meeting of The American Association for the Study of Liver Diseases (AASLD), 2015.
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top