Pharmacokinetic, Efficacy and Safety of BT524 in Patients With Congenital Fibrinogen Deficiency

Summary

This was a prospective, open-label, multicenter, phase I/III study investigating the 14-day single-dose pharmacokinetic and pharmacodynamic properties, efficacy and safety of BT524 following intravenous administration in the treatment or prophylaxis of bleeding in patients with congenital afibrinogenemia or severe congenital hypofibrinogenemia.

Timeline

Start

2013-03

Primary completion

2020-05-18

Completion

2020-11-18

Publications

• Khayat CD, El-Beshlawy A, Omar N, Belhadjali EG, Khelif A, Adolf S, Miesbach W, Aigner S, Abraha S, Schuettrumpf J, Boehm H. Efficacy and safety of prophylaxis and treatment of bleeding events with a novel fibrinogen concentrate from human plasma in patients with congenital fibrinogen deficiency. Thromb Res. 2026 Mar;259:109616. doi: 10.1016/j.thromres.2026.109616. Epub 2026 Feb 10.

Drugs

Indications