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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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Trial Profile

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: 08 Dec 2025

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At a glance

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

Most Recent Events

  • 13 Nov 2025 According to a Grifols media release, the obtains approval for new human fibrinogen Prufibry in Germany.
  • 13 Nov 2025 According to a Grifols media release, company has also submitted a biologic license application for the fibrinogen concentrate in the U.S., with regulatory determination expected by the end of the year.
  • 23 Jun 2025 According to a Biotest media release, AdFIrst data have been previously presented at congresses including the International Symposium on Intensive Care & Emergency Medicine (ISICEM); Network for the Advancement of Patient Blood Management, Haemostasis and Thrombosis (NATA); and the European Society of Anaesthesiology and Intensive Care (ESAIC).

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