Pharmacokinetic, Efficacy, and Safety Study of Octafibrin Compared to Haemocomplettan/Riastap

Inclusion Criteria: * Age ≥ 12 years. * Documented congenital fibrinogen deficiency (afibrinogenemia). Exclusion Criteria: * Life expectancy \> 6 month. * Bleeding disorder other than congenital fibrinogen deficiency. * Presence or history of hypersensitivity to study medication. * Presence or history of deep vein thrombosis or pulmonary embolism within 1 year prior to enrollment. * Presence or history of arterial thrombosis with 1 year prior to enrollment. * Hypersensitivity to human plasma products. * Acute bleeding. * Pregnant or currently breast-feeding women. * Suspicion of an anti-fibrinogen inhibitor as indicated by previous in vivo recovery (if available). * Blood or plasma donation in the 3 months prior to enrollment. * Human immunodeficiency virus (HIV) positive with a viral load \> 200 particles/µl or \> 400000 copies/mL. * End-stage liver disease. * History of oesophageal varicose bleeding.