A Phase 2, Open-label Study to Investigate the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Subjects

Trial Profile

A Phase 2, Open-label Study to Investigate the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Subjects

Completed
Phase of Trial: Phase II

Latest Information Update: 18 Jan 2018

At a glance

  • Drugs Daclatasvir (Primary) ; Simeprevir (Primary)
  • Indications Hepatitis C
  • Focus Therapeutic Use
  • Acronyms COMMIT
  • 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.
    • 04 May 2016 Status changed from active, no longer recruiting to completed.
    • 17 Apr 2016 Interim results (n=106) presented at The International Liver Congress™ 2016
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