Trial Outcomes & Findings for Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A (NCT NCT00666406)
NCT ID: NCT00666406
Last Updated: 2021-05-19
Results Overview
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
COMPLETED
PHASE4
9 participants
0-30 minutes before infusion up to 48 hours post-infusion
2021-05-19
Participant Flow
9 unique participants enrolled and treated at a single study site in Germany
Participants required a factor VIII (FVIII) washout period ≥48 hours before receiving any pharmacokinetic (PK) infusions and could not be actively bleeding at the time of the infusion.
Participant milestones
| Measure |
Advate rAHF-PFM Then Recombinate rAHF
First infusion - Advate Antihemophilic Factor (Recombinant)-Plasma/Albumin Free Method (rAHF-PFM): Infusion of 50 +/- 5 IU/kg bodyweight Second infusion - Recombinate Antihemophilic Factor (Recombinant) (rAHF): Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF Then Advate rAHF-PFM
First infusion - Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight Second infusion - Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
First PK Infusion
STARTED
|
6
|
3
|
|
First PK Infusion
COMPLETED
|
6
|
3
|
|
First PK Infusion
NOT COMPLETED
|
0
|
0
|
|
Second PK Infusion
STARTED
|
6
|
3
|
|
Second PK Infusion
COMPLETED
|
6
|
3
|
|
Second PK Infusion
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A
Baseline characteristics by cohort
| Measure |
All Study Participants
n=9 Participants
Includes groups randomized to receive Advate rAHF-PFM and Recombinate rAHF first.
|
|---|---|
|
Age, Continuous
|
37.3 years
STANDARD_DEVIATION 14.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
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)
|
1104 IU*h/dL
Interval 950.0 to 1328.0
|
1294 IU*h/dL
Interval 1149.0 to 1536.0
|
PRIMARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
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)
|
1180 IU*h/dL
Interval 999.0 to 1497.0
|
1358 IU*h/dL
Interval 1146.0 to 1547.0
|
PRIMARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
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)
|
833 IU*h/dL
Interval 697.0 to 970.0
|
901 IU*h/dL
Interval 629.0 to 1070.0
|
PRIMARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
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)
|
1505 IU*h/dL
Interval 1215.0 to 1741.0
|
1664 IU*h/dL
Interval 1340.0 to 1911.0
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
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
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
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)
|
1190 IU*h/dL
Interval 1031.0 to 1360.0
|
1393 IU*h/dL
Interval 1232.0 to 1574.0
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
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)
|
1282 IU*h/dL
Interval 1037.0 to 1626.0
|
1452 IU*h/dL
Interval 1137.0 to 1696.0
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
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)
|
874 IU*h/dL
Interval 734.0 to 1031.0
|
926 IU*h/dL
Interval 655.0 to 1152.0
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
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)
|
1598 IU*h/dL
Interval 1340.0 to 1923.0
|
1731 IU*h/dL
Interval 1453.0 to 2162.0
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Systemic Clearance (Cl). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
|
4.31 mL/h/kg
Interval 3.92 to 4.85
|
3.68 mL/h/kg
Interval 3.41 to 4.19
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Systemic Clearance (Cl). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
4.00 mL/h/kg
Interval 3.28 to 4.88
|
3.53 mL/h/kg
Interval 3.03 to 4.43
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Systemic Clearance (Cl). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
5.87 mL/h/kg
Interval 4.4 to 7.35
|
5.53 mL/h/kg
Interval 4.28 to 8.19
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Systemic clearance in mL/kg/h will be calculated as the dose in IU/kg divided by the total area under the curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Systemic Clearance (Cl). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
3.21 mL/h/kg
Interval 2.63 to 3.85
|
2.96 mL/h/kg
Interval 2.35 to 3.79
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Maximum Plasma Concentration (C-max). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
|
93 IU/dL
Interval 74.0 to 112.0
|
108 IU/dL
Interval 91.0 to 130.0
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Maximum Plasma Concentration (C-max). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
104 IU/dL
Interval 79.0 to 148.0
|
119 IU/dL
Interval 104.0 to 144.0
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Maximum Plasma Concentration (C-max). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
78 IU/dL
Interval 66.0 to 100.0
|
94 IU/dL
Interval 72.0 to 149.0
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
C-max will be calculated as the maximum concentration following infusion of either Advate or Recombinate.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Maximum Plasma Concentration (C-max). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
100 IU/dL
Interval 72.0 to 121.0
|
112 IU/dL
Interval 92.0 to 137.0
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
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).
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Terminal Half-life. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
|
10.7 hours
Interval 8.3 to 12.8
|
10.9 hours
Interval 9.1 to 13.1
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Terminal Half-life. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
11.7 hours
Interval 8.5 to 13.5
|
10.8 hours
Interval 8.2 to 12.2
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Terminal Half-life. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
9.5 hours
Interval 7.5 to 12.8
|
9.9 hours
Interval 7.6 to 11.5
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Computed from the terminal or disposition rate constant obtained from log-linear fitting using the least squares deviation to the last five quantifiable concentrations.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Terminal Half-life. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
12.4 hours
Interval 9.3 to 14.2
|
12.1 hours
Interval 8.9 to 13.9
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Increase in factor VIII concentration from pre- to post-infusion.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Incremental Recovery. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
|
1.81 (IU/dL)/(IU/kg)
Interval 1.52 to 2.1
|
2.11 (IU/dL)/(IU/kg)
Interval 1.89 to 2.42
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
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.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Incremental Recovery. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
2.04 (IU/dL)/(IU/kg)
Interval 1.53 to 2.7
|
2.33 (IU/dL)/(IU/kg)
Interval 2.02 to 2.69
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Increase in factor VIII concentration from pre- to post-infusion
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Incremental Recovery. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
1.53 (IU/dL)/(IU/kg)
Interval 1.24 to 1.82
|
1.84 (IU/dL)/(IU/kg)
Interval 1.49 to 2.82
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Increase in factor VIII concentration from pre- to post-infusion
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Incremental Recovery. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
1.94 (IU/dL)/(IU/kg)
Interval 1.44 to 2.27
|
2.19 (IU/dL)/(IU/kg)
Interval 1.74 to 2.64
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Mean Residence Time (MRT). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
|
14.1 Hours
Interval 11.0 to 17.5
|
14.4 Hours
Interval 12.1 to 17.6
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Mean Residence Time (MRT). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
15.1 Hours
Interval 10.9 to 18.6
|
14.2 Hours
Interval 10.3 to 16.2
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Mean Residence Time (MRT). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
12.5 Hours
Interval 9.1 to 16.7
|
12.8 Hours
Interval 10.1 to 16.4
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
The MRT in hours will be calculated as total area under the moment curve divided by the total area under the curve.
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Mean Residence Time (MRT). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
17.3 Hours
Interval 12.4 to 19.6
|
16.9 Hours
Interval 13.2 to 19.6
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Time to Reach the Maximum Plasma Concentration (Tmax). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
|
0.25 Hours
Interval 0.25 to 0.25
|
0.25 Hours
Interval 0.25 to 0.25
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Time to Reach the Maximum Plasma Concentration (Tmax). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
0.31 Hours
Interval 0.25 to 0.5
|
0.42 Hours
Interval 0.25 to 1.0
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
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)
|
0.45 Hours
Interval 0.25 to 1.0
|
0.31 Hours
Interval 0.25 to 0.5
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Tmax in hours was defined as the minimum time to reach Maximum plasma concentration (Cmax).
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Time to Reach the Maximum Plasma Concentration (Tmax). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
0.38 Hours
Interval 0.25 to 1.0
|
0.51 Hours
Interval 0.25 to 3.0
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Computed as weight-adjusted Clearance \* Mean Residence Time
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Volume of Distribution at Steady State (Vss). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
|
60.8 mL/kg
Interval 48.2 to 75.7
|
52.9 mL/kg
Interval 43.9 to 62.0
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Computed as weight-adjusted Clearance (CL) \* Mean Residence Time
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Volume of Distribution at Steady State (Vss). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
60.4 mL/kg
Interval 45.5 to 76.6
|
50.2 mL/kg
Interval 45.4 to 58.2
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Computed as weight-adjusted CL \* Mean Residence Time
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
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)
|
73.2 mL/kg
Interval 54.6 to 87.5
|
70.9 mL/kg
Interval 67.5 to 89.5
|
SECONDARY outcome
Timeframe: 0-30 minutes before infusion up to 48 hours post-infusionPopulation: All enrolled participants
Computed as weight-adjusted CL \* Mean Residence Time
Outcome measures
| Measure |
Advate rAHF-PFM
n=9 Participants
Advate rAHF-PFM: Infusion of 50 +/- 5 IU/kg bodyweight
|
Recombinate rAHF
n=9 Participants
Recombinate rAHF: Infusion of 50 +/- 5 IU/kg bodyweight
|
|---|---|---|
|
Volume of Distribution at Steady State (Vss). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
|
55.6 mL/kg
Interval 40.4 to 69.1
|
50.0 mL/kg
Interval 39.8 to 63.8
|
Adverse Events
All Study Participants
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Baxter requires a review of results communications (e.g., for confidential information and/or manuscript amendment proposals which do not negatively influence the scientific character of impartiality) ≥30 days prior to submission or communication. Baxter may request an additional delay of ≤60 days (e.g., for intellectual property protection)
- Publication restrictions are in place
Restriction type: OTHER