Fibrinogen Concentrate (Human) - Efficacy and Safety Study

Inclusion Criteria: * Documented congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia), expected to require treatment for bleeding * Presenting with an episode of acute bleeding (either spontaneous or after trauma) not requiring surgery * Provide informed consent Exclusion Criteria: * Life expectancy \< 6 months * Bleeding disorder other than congenital fibrinogen deficiency, but including dysfibrinogenemia * Treatment with any investigational medicinal product (IMP) in the 30 days prior to enrollment * Treatment with any fibrinogen concentrate or other fibrinogen containing blood product in the 2 weeks prior to enrollment * Treatment with any coagulation active drug (i.e., non-steroidal-antirheumatics, warfarin, cumarin derivates, platelet aggregation inhibitors) in 1 week prior to enrollment or as a planned or expected medication during the time period from Day 1 until 24 hours after the last FCH infusion * Presence or history of hypersensitivity to FCH * Presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior to enrollment * Presence or history of arterial thrombosis within 1 year prior to enrollment * Presence or history of hypersensitivity to human plasma proteins * Presence or history of esophageal varicose bleeding * End stage liver disease (i.e., Child Pugh score B or C) * Planned or expected surgery (i.e., for bleedings from aneurysm or splenic rupture) * Pregnancy, or an intention to become pregnant during the study * Currently breast-feeding, or with the intention of breast-feeding during the study * Human immunodeficiency virus (HIV) positive * Polytrauma, present or within 6 months prior to enrollment * Suspicion of an anti-fibrinogen inhibitor as indicated by previous in-vivo recovery (IVR), if available (\< 0.5 (mg/dL)/(mg/kg)) * Previous inclusion and treatment in the prospective part of the study * Participation in any clinical study in the 30 days prior to enrollment