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

Congenital Afibrinogenemia Clinical Trial

Official title:
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

Status Completed

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02065882
Study type	Interventional
Source	Biotest
Contact
Status	Completed
Phase	Phase 3
Start date	March 2013
Completion date	November 18, 2020

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See also
	Status	Clinical Trial	Phase
	Completed	`NCT02281500` - Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia	Phase 1/Phase 2
	Withdrawn	`NCT04636268` - FIB Grifols Congenital Deficiency for On-demand Treatment and Surgical Prophylaxis	Phase 3