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.