An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX P/N Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure

Trial Profile

An Open-label, Randomized, Multicenter Phase IIIb Study to Assess the Efficacy, Safety and Tolerance of BERIPLEX P/N Compared With Plasma for Rapid Reversal of Coagulopathy Induced by Vitamin K Antagonists in Subjects Requiring an Urgent Surgical Procedure

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Apr 2016

At a glance

  • Drugs Prothrombin complex concentrate (Primary) ; Plasma
  • Indications Haemorrhage
  • Focus Therapeutic Use
  • Sponsors CSL Behring
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 23 May 2015 Results published in the Lancet.
    • 20 Mar 2015 According to a CSL Behring media release, results from this study were published in The Lancet.
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