Human Fibrinogen - Pharmacokinetics

CSL Behring15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fibrinogen Deficiency

Interventions

Human Fibrinogen ConcentrateBIOLOGICAL

Single intravenous infusion of 70 mg/kg body weight

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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

Locations (15)

Contact CSL Behring for facility details

Aurora, Colorado, United States

Contact CSL Behring for facility details

St. Petersburg, Florida, United States

Outcomes

Primary Outcomes

Maximum Clot Firmness (MCF)

MCF is a functional parameter that depends on the activation of coagulation, the fibrinogen content of the sample (in plasma), and the polymerization and crosslinking of the fibrin network. MCF was determined by rotational thromboelastometry (ROTEM) testing.

Time frame: Pre-infusion and 1 hour post-infusion

Secondary Outcomes

Terminal Elimination Half-life (t1/2)

t1/2 for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

Time frame: 0.5 hours to 13 days post-infusion

Maximum Concentration (Cmax)

Cmax for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

Time frame: Pre-infusion to 13 days post-infusion

Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose

AUC for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

Time frame: Pre-infusion to 13 days post-infusion

Clearance (Cl)

Cl for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

Time frame: Pre-infusion to 13 days post-infusion

Mean Residence Time (MRT)

MRT for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

Time frame: Pre-infusion to 13 days post-infusion

Volume of Distribution at Steady State (Vss)

Data from ClinicalTrials.gov

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