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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jul 2023

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At a glance

Most Recent Events

  • 26 Jul 2023 According to Octapharma media release, based on results of this study the Balfaxar (prothrombin complex concentrate) has received U.S. Food and Drug Administration (FDA) approval for the urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with need for urgent surgery or invasive procedures.
  • 06 Jun 2023 According to Octapharma media release, dosing and haemostatic efficacy results in patients on VKA anticoagulation who need urgent surgery will be presented at the 31st Congress of the International Society on Thrombosis and Haemostasis (ISTH) on June 24-28, 2023, in Montreal, Canada.
  • 13 Dec 2022 Primary endpoint has been met (Hemostatic efficacy rating), as per Results presented at the 64th American Society of Hematology Annual Meeting and Exposition

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