Human Fibrinogen Concentrate (FGTW) in Pediatric Patients With Congenital Fibrinogen Deficiency

Clinical Pharmacology, Efficacy and Safety Study of FGTW in Paediatric Patients With Severe Congenital Fibrinogen Deficiency

The aim of the study is to evaluate clinical pharmacology, efficacy and safety of FGTW in pediatric patients with congenital fibrinogen deficiency.

Inclusion Criteria:

• Signed and dated informed consent form by parents or a legal representative
• Age less or equal to 12 years old
• Patients with inherited afibrinogenemia or severe inherited hypofibrinogenemia
• Negative results on HCG-based pregnancy test for females of childbearing potential (presence of menstruation)

Exclusion Criteria:

• Dysfibrinogenemia
• Acquired fibrinogen deficiency
• Suspected present or past anticoagulation inhibitor
• Personal history of venous or arterial thrombosis or thromboembolic event
• Co-morbidity with other/unrelated coagulopathies
• Administration of any fibrinogen concentrate or fibrinogen containing blood product during the last 15 days
• Permanent treatment with antithrombotic or anti-platelet agents such as heparins, anti-IIa or anti-Xa agents, aspirin, clopidogrel and NSAIDs.