Development pipeline

Fibrinogen (BT-524)

BT-524 is a human fibrinogen concentrate purified from human plasma.

Fibrinogen is a plasma protein produced by the liver, which is an important component of blood clotting. A deficiency of autologous fibrinogen means that the blood’s ability to clot is impaired, which leads to a greatly increased risk of bleeding and additionally to a delay in bleeding cessation.

In the case of congenital fibrinogen deficiency patients can not produce sufficient or any fibrinogen. In acquired fibrinogen deficiency, on the other hand, patients lose fibrinogen because of heavy bleeding, for example due to severe injuries and surgery. In both cases, fibrinogen must be supplied again to stop bleeding.

The fibrinogen (BT-524) developed by Biotest is currently being investigated clinically in a multinational phase I/III trial in patients with congenital fibrinogen deficiency.

Press releases

Biotest proceeds into phase III programme in congenital...

01.12.2015, News

Biotest proceeds into phase III programme in congenital fibrinogen deficiency - Fibrinogen concentrate shows good efficacy and safety profile based on preliminary data - Preliminary data ... [More]

Biotest starts clinical development programme of human ...

06.12.2012, News

Biotest starts clinical development programme of human fibrinogen concentrate to treat serious, life-threatening bleeding - Approval of study protocol to conduct a phase I/II clinical trial - ... [More]

Clinical trials

Title

Indication

Status

 
Fibrinogen (Study 984) Congenital fibrinogen deficiency Study ongoing

A prospective, open-label, uncontrolled, single dose phase I/III study investigating pharmacokinetic properties, efficacy, safety, and tolerability of BT524 (fibrinogen concentrate from human plasma) in patients with congenital fibrinogen deficiency

Link clinicaltrials.gov