The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe hemophilia A (factor VIII level \< 1%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
9
Infusion of 50 +/- 5 IU/kg bodyweight
Infusion of 50 +/- 5 IU/kg bodyweight
Unnamed facility
Bonn, Germany
Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. One-Stage Activated Partial Thromboplastin Time (aPTT) -Based Assay Performed at Central Laboratory (Medical University Vienna)
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve. FVIII activity measurement
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Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Systemic Clearance (Cl). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Systemic Clearance (Cl). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Systemic Clearance (Cl). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Systemic Clearance (Cl). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Maximum Plasma Concentration (C-max). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Maximum Plasma Concentration (C-max). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Maximum Plasma Concentration (C-max). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Maximum Plasma Concentration (C-max). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Terminal Half-life. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations (9 to 48 hours).
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Terminal Half-life. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Terminal Half-life. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Terminal Half-life. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Incremental Recovery. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
Increase in factor VIII concentration from pre- to post-infusion.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Incremental Recovery. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Computed from the terminal or disposition rate constant obtained from log\_e -linear fitting using the least squares deviation to the last five quantifiable concentrations.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Incremental Recovery. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Increase in factor VIII concentration from pre- to post-infusion
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Incremental Recovery. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Increase in factor VIII concentration from pre- to post-infusion
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Mean Residence Time (MRT). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Mean Residence Time (MRT). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Mean Residence Time (MRT). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Mean Residence Time (MRT). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Time to Reach the Maximum Plasma Concentration (Tmax). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Time to Reach the Maximum Plasma Concentration (Tmax). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Time to Reach the Maximum Plasma Concentration (Tmax). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Time to Reach the Maximum Plasma Concentration (Tmax). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Volume of Distribution at Steady State (Vss). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
Computed as weight-adjusted Clearance \* Mean Residence Time
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Volume of Distribution at Steady State (Vss). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Computed as weight-adjusted Clearance (CL) \* Mean Residence Time
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Volume of Distribution at Steady State (Vss). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Computed as weight-adjusted CL \* Mean Residence Time
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Volume of Distribution at Steady State (Vss). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Computed as weight-adjusted CL \* Mean Residence Time
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion