Human Fibrinogen - Pharmacokinetics

Phase 2

Completed

• Conditions: Fibrinogen Deficiency
• Interventions: Biological: Human Fibrinogen Concentrate

• Registration Number: NCT00496262
• Lead Sponsor: CSL Behring

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-03
• Study First Posted: 2007-07-04
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Results First Submitted: 2009-05-19
• Results First Submitted QC: 2009-05-19
• Results First Posted: 2009-07-10
• Status Verified: 2011-02
• Last Update Submitted: 2016-07-27
• Last Update Posted: 2016-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Human Fibrinogen Concentrate	Human Fibrinogen Concentrate	-

Primary Outcome Measures

Name	Time	Method
Maximum Clot Firmness (MCF)	Pre-infusion and 1 hour post-infusion	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.

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose	Pre-infusion to 13 days post-infusion	AUC for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Classical In Vivo Recovery (IVR)	Pre-infusion to 4 hours post-infusion	Maximum fibrinogen activity increase in plasma times plasma volume per mg/kg dose
Maximum Concentration (Cmax)	Pre-infusion to 13 days post-infusion	Cmax for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Clearance (Cl)	Pre-infusion to 13 days post-infusion	Cl for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Volume of Distribution at Steady State (Vss)	Pre-infusion to 13 days post-infusion	Vss for fibrinogen activity was determined from samples taken at 11 timepoints during the specified time frame.
Incremental In Vivo Recovery (IVR)	Pre-infusion to 4 hours post-infusion	Maximum fibrinogen activity increase in plasma per mg/kg dosed
Terminal Elimination Half-life (t1/2)	0.5 hours to 13 days post-infusion	t1/2 for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.
Mean Residence Time (MRT)	Pre-infusion to 13 days post-infusion	MRT for fibrinogen activity was determined from samples taken at 12 timepoints during the specified time frame.

Trial Locations

Locations (1)

Contact CSL Behring for facility details; 🇮🇹 Vicenza, Italy