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An Open-label, Uncontrolled, Single-arm, Multicenter Phase IIIb Study to Assess the Efficacy and Safety of BE1116 in Japanese Subjects Receiving Vitamin K Antagonist Therapy With an Elevated INR and Either Acute Major Bleeding or a Requirement for Urgent Reversal of Vitamin K Antagonist Therapy for a Surgical or Invasive Medical Procedure

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An Open-label, Uncontrolled, Single-arm, Multicenter Phase IIIb Study to Assess the Efficacy and Safety of BE1116 in Japanese Subjects Receiving Vitamin K Antagonist Therapy With an Elevated INR and Either Acute Major Bleeding or a Requirement for Urgent Reversal of Vitamin K Antagonist Therapy for a Surgical or Invasive Medical Procedure

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Prothrombin complex concentrate (Primary)
  • Indications Haemorrhage; Surgical blood loss
  • Focus Registrational; Therapeutic Use
  • Sponsors CSL Behring

    • Most Recent Events

    • 01 Dec 2017 Results published in the International Journal of Hematology
    • 01 Apr 2016 Status changed from active, no longer recruiting to completed, according to ClinicalTrials.gov record.
    • 27 Jan 2016 Planned End Date changed from 1 Feb 2016 to 1 Mar 2016 as reported by ClinicalTrials.gov record.

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