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A Randomized, Active-controlled, Multicenter, Phase III Study Investigating Efficacy and Safety of Intra-operative Use of BT524 (Human Fibrinogen Concentrate) in Subjects Undergoing Major Spinal or Abdominal Surgery (AdFIrst)

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A Randomized, Active-controlled, Multicenter, Phase III Study Investigating Efficacy and Safety of Intra-operative Use of BT524 (Human Fibrinogen Concentrate) in Subjects Undergoing Major Spinal or Abdominal Surgery (AdFIrst)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Oct 2024

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At a glance

  • Drugs Fibrinogen (Primary)
  • Indications Afibrinogenaemia
  • Focus Registrational; Therapeutic Use
  • Acronyms AdFIrst
  • Sponsors Biotest AG

    • Most Recent Events

    • 14 Feb 2024 Results published in Biotest AG the Media Release
    • 14 Feb 2024 Primary endpoint (Efficacy: Intra-operative blood loss after decision to treat the subject with IMP until the end of surgery as measured by amount of blood from blood suction unit and amount of blood from surgical cloths and compresses.) has been met, According to Grifols media release.
    • 14 Feb 2024 Topline Results published in the Media Release

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