Human Fibrinogen - Pharmacokinetics

CSL Behring

Status and phase: Completed; Phase 2

Conditions: Fibrinogen Deficiency

Treatments: Biological: Human Fibrinogen Concentrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00496262

BI3023_2001

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Human Fibrinogen Concentrate

Experimental group

Treatment:

Biological: Human Fibrinogen Concentrate