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: 13 Jun 2017
At a glance
- Drugs Fibrinogen (Primary)
- Indications Afibrinogenaemia; Congenital disorders; Haemorrhage
- Focus First in man; Pharmacokinetics
- Sponsors Biotest AG
- 12 Jun 2016 This trial is discontinued in Italy as per European Clinical Trials Database record.
- 02 Jun 2016 Planned number of patients changed from 20 to 35.
- 02 Jun 2016 Planned End Date changed from 1 Oct 2016 to 1 Oct 2018.