Phase 2
Completed N=15
Human Fibrinogen - Pharmacokinetics
Fibrinogen Deficiency
Source: ClinicalTrials.gov NCT00496262 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2009
Primary outcomePrimary: Maximum Clot Firmness (MCF) — 0; 8.9 millimeters — p=<0.0001
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.
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 | — |
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
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. Informational only — not medical advice.