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
Phase of Trial: Phase III
Latest Information Update: 11 Aug 2018
At a glance
- Drugs Fibrinogen (Primary)
- Indications Afibrinogenaemia
- Focus Registrational; Therapeutic Use
- Acronyms AdFIrst
- Sponsors Biotest AG
- 31 Aug 2018 Biomarkers information updated
- 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.