Last updated on June 2016

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

Brief description of study

The purpose of the study is to investigate pharmacokinetics, efficacy and safety of BT524 in patients with congenital fibrinogen deficiency.

Detailed Study Description

The present study is designed as a prospective, open-label, multicentre, phase I/III study investigating the 14 day single-dose pharmacokinetic 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.

Clinical Study Identifier: NCT02065882

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