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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: 22 Jul 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

  • 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).
  • 23 Jun 2025 According to a Biotest media release, the company expects finalizing regulatory approval processes in Europe and the United States. Subsequent expected launch in Europe will be later this year and in early 2026 in USA- post FDA approval.
  • 23 Jun 2025 According to a Biotest media release, positive results from this study will also be presented on 24 June 2025 as part of three abstracts at the currently ongoing International Society on Thrombosis and Haemostasis (ISTH) 2025 Congress.

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