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: 26 Jul 2019
Price : $35 *
At a glance
- Drugs Fibrinogen (Primary)
- Indications Afibrinogenaemia; Congenital disorders; Haemorrhage
- Focus First in man; Pharmacokinetics
- Sponsors Biotest AG
- 24 Jul 2019 Planned End Date changed from 1 Oct 2018 to 1 Nov 2020.
- 24 Jul 2019 Planned primary completion date changed from 1 May 2018 to 1 Mar 2020.
- 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.