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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: 20 Jun 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

  • 09 Jan 2025 According to a Grifols media release, the company announced that The European equivalent, a Marketing Authorization Application (MAA), was submitted for several countries in October 2024 and it also expects to begin treating patients in Europe starting in the second half of 2025, with rollout in the U.S. planned for the first part of 2026.
  • 09 Jan 2025 According to a Grifols media release, the company announced it has submitted a Biologics License Application (BLA) for its new potential fibrinogen treatment to the United States Food and Drug Administration (FDA).
  • 09 Jan 2025 According to a Biotest Pharmaceuticals media release, full trial results are expected to be published in a medical journal later in 2025.

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