A prospective, open-label, phase I/II study investigating pharmacokinetic properties of BT524 and efficacy and safety of BT524 in the treatment and prophylaxis of bleeding in patients with congenital fibrinogen deficiency
Phase of Trial: Phase I/II
Latest Information Update: 15 Mar 2018
At a glance
- Drugs Fibrinogen (Primary)
- Indications Afibrinogenaemia; Congenital disorders; Haemorrhage
- Focus First in man; Pharmacokinetics
- Sponsors Biotest AG
- 15 Mar 2018 According to a Biotest AG media release, the results of this and another study (700288385) 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, based on the first preliminary results, the EMA has agreed on the paediatric investigation plan for treatment of children below 6 years in this study.
- 12 Jun 2016 This trial is discontinued in Italy as per European Clinical Trials Database record.