A Phase III, Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of OCTAPLEX, a Four-factor Prothrombin Complex Concentrate (4F-PCC), Compared to the 4F-PCC Beriplex P/N (Kcentra), for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.

Trial Profile

A Phase III, Randomized, Double-blind, Multicenter Study to Assess the Efficacy and Safety of OCTAPLEX, a Four-factor Prothrombin Complex Concentrate (4F-PCC), Compared to the 4F-PCC Beriplex P/N (Kcentra), for the Reversal of Vitamin K Antagonist (VKA) Induced Anticoagulation in Patients Needing Urgent Surgery With Significant Bleeding Risk.

Recruiting
Phase of Trial: Phase III

Latest Information Update: 31 Aug 2017

At a glance

  • Drugs Prothrombin complex concentrate (Primary)
  • Indications Surgical blood loss
  • Focus Registrational; Therapeutic Use
  • Sponsors Octapharma
  • Most Recent Events

    • 09 May 2017 Status changed from not yet recruiting to recruiting.
    • 22 Nov 2016 Planned initiation date changed from 1 Dec 2016 to 1 Mar 2017.
    • 18 Apr 2016 New trial record
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