Efficacy and Safety Study of Octafibrin for On-demand Treatment of Acute Bleeding and to Prevent Bleeding During and After Surgery

Inclusion Criteria: * Aged ≥12 years (only 18 and above in Russia) * Documented diagnosis of congenital fibrinogen deficiency, expected to require on-demand treatment for bleeding or surgical prophylaxis: * Fibrinogen deficiency manifested as afibrinogenaemia or severe hypofibrinogenaemia. * Historical plasma fibrinogen activity of \<50 mg/dL or levels below the limit of detection of the local assay method. * Expected to have an acute bleeding episode (spontaneous or after trauma) or planning to undergo elective surgery. * Informed consent signed by the subject or legal guardian. Exclusion Criteria: * Life expectancy \<6 months. * Bleeding disorder other than congenital fibrinogen deficiency, including dysfibrinogenaemia. * Prophylactic treatment with a fibrinogen concentrate. Treatment with: * Any fibrinogen concentrate or other fibrinogen-containing blood product within 2 weeks prior to start of treatment for the bleeding episode or surgery. * Any coagulation-active drug (i.e., non-steroidal anti-inflammatory drugs, warfarin, coumarin derivatives, platelet aggregation inhibitors) within 1 week prior to start of treatment for the bleeding episode or surgery, or as a planned or expected medication during the time period from Day 1 until 24 hours (i.e., 1 day) after the last Octafibrin infusion. Presence or history of: * Hypersensitivity to study medication. * Deep vein thrombosis or pulmonary embolism within 1 year prior to start of treatment for the bleeding episode o…