Human Fibrinogen - Pharmacokinetics

Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency

This study evaluated the single-dose pharmacokinetics of human fibrinogen concentrate and clot strength (maximum clot firmness [MCF]) in subjects with congenital fibrinogen deficiency. MCF was measured to demonstrate the functional activity of replacement fibrinogen when a fixed dose of human fibrinogen concentrate was administered.

Inclusion Criteria:

• Aged ≥ 6 years
• Documented congenital fibrinogen deficiency: fibrinogen deficiency manifested as afibrinogenemia with plasma fibrinogen activity and antigen at screening undetectable (i.e. < 20 mg/dL)
• Informed consent signed by subject or legal guardian

Exclusion Criteria:

• Presence or history of hypersensitivity to Human Fibrinogen Concentrate or human plasma proteins,
• Presence or history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis
• Acute bleeding
• History of esophageal varicose bleeding
• End stage liver disease (i.e. Child-Pugh score B or C)
• Planned major surgery with a need for blood transfusion during the PK blood sampling period
• Polytrauma within 1 year prior to enrollment