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 ]
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