Phase 2 N=15 Treatment

Human Fibrinogen - Pharmacokinetics

Fibrinogen Deficiency

Bottom Line

View on ClinicalTrials.gov: NCT00496262 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2009

Primary outcome: Primary: Maximum Clot Firmness (MCF) — 0; 8.9 millimeters — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Human Fibrinogen Concentrate (Biological)
Age: Pediatric, Adult, Older Adult · 6+ yrs
Sex: All
Sponsor: CSL Behring
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Maximum Clot Firmness (MCF)	0; 8.9	<0.0001 sig
SECONDARY Terminal Elimination Half-life (t1/2)	78.7	—
SECONDARY Maximum Concentration (Cmax)	1.4	—
SECONDARY Area Under the Concentration-time Curve (AUC) Standardized for 70 mg/kg Body Weight Dose	124.3	—
SECONDARY Clearance (Cl)	0.59	—
SECONDARY Mean Residence Time (MRT)	92.8	—
SECONDARY Volume of Distribution at Steady State (Vss)	52.7	—
SECONDARY Incremental In Vivo Recovery (IVR)	1.7	—
SECONDARY Classical In Vivo Recovery (IVR)	61.8	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00496262). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.