At a glance
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A Prospective, Open-label, Phase I/III 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
In Brief
A Phase 3 clinical trial evaluating BT524 (Part I) and BT524 (Part II) for Congenital Afibrinogenemia and Congenital Hypofibrinogenemia. Completed, enrolled 67 participants across 6 sites in 5 countries.
Detailed 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.
Study Details
Timeline
Interventions
Single intravenous infusion of 70 mg BT524 per kg body weight.
Single or repetitive intravenous infusion(s) of BT524, depending on the severity of the disorder, location and extent of the bleeding and patient's clinical condition. Dosage based on individual body weight and fibrinogen level.