Clinical Trial: Human Fibrinogen - Pharmacokinetics

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Pharmacokinetics of Haemocomplettan® P in Subjects With Congenital Fibrinogen Deficiency

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 Summary:
Sponsor: CSL Behring

Current Primary Outcome: Maximum Clot Firmness (MCF) [ Time Frame: 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.


Original Primary Outcome:

  • To compare maximum clot strength (MCF) as a surrogate marker for hemostatic efficacy before and after administration of Human Fibrinogen
  • To demonstrate that MCF 1 hour after administration of 70 mg/kg b.w. of Human Fibrinogen is significantly higher compared to baseline
  • To determine the single dose pharmacokinetics of Human Fibrinogen in subjects with congenital fibrinogen deficiency


Current Secondary Outcome:

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


Original Secondary Outcome: To assess the safety of Human Fibrinogen in subjects with congenital fibrinogen deficiency

Information By: CSL Behring

Dates:
Date Received: July 3, 2007
Date Started: July 2007
Date Completion:
Last Updated: July 27, 2016
Last Verified: February 2011