| Primary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | IU*h/dL | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001104(950 to 1328)
- OG0011294(1149 to 1536)
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | | | | | Ratio of the geometric means | 1.173 | | | 2-Sided | 90 | 1.089 | 1.262 | | | | | Superiority or Other (legacy) | | |
|
| Primary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | IU*h/dL | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Primary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | IU*h/dL | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Primary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | IU*h/dL | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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 | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | IU*h/dL | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | IU*h/dL | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | IU*h/dL | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | IU*h/dL | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | mL/h/kg | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | mL/h/kg | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | mL/h/kg | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | mL/h/kg | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | IU/dL | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | IU/dL | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | IU/dL | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | IU/dL | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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). | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | hours | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | hours | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | hours | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | hours | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | Incremental Recovery. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna) | Increase in factor VIII concentration from pre- to post-infusion. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | (IU/dL)/(IU/kg) | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | (IU/dL)/(IU/kg) | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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 | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | (IU/dL)/(IU/kg) | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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 | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | (IU/dL)/(IU/kg) | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | Hours | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | Hours | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | Hours | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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. | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | Hours | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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). | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | Hours | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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). | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | Hours | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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). | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | Hours | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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). | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | Hours | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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 | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | mL/kg | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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 | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | mL/kg | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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 | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | mL/kg | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |
| Secondary | 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 | All enrolled participants | Posted | | Geometric Mean | 90% Confidence Interval | mL/kg | | 0-30 minutes before infusion up to 48 hours post-infusion | | | | ID | Title | Description |
|---|
| OG000 | Advate rAHF-PFM | Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight | | OG001 | Recombinate rAHF | Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight |
| |