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 Spine Surgery

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 Spine Surgery

Recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Apr 2018

At a glance

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

    • 15 Mar 2018 According to a Biotest AG media release, the results of this and another study (700237596) will serve as a basis for the marketing authorisation of fibrinogen concentrate BT524 for treatment of patients with congenital and acquired fibrinogen deficiency.
    • 15 Mar 2018 According to a Biotest AG media release, first patient has been dosed.
    • 07 Sep 2017 New trial record
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