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

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.