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Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A

Primary Purpose

Hemophilia A

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM)
Recombinant Factor VIII (rAHF)
Sponsored by
Baxalta now part of Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemophilia A

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent obtained from participant or legally authorized representative
  • 15-60 years old
  • Factor VIII level < 1% as documented by previously measured factor VIII and genotyping
  • Previously treated with factor VIII concentrate(s) for a minimum of at least 150 exposure days (as documented by the study site investigator) prior to study entry
  • Observed decrease of efficacy by subject and/or treating physician after being switched from Recombinate rAHF to Advate rAHF-PFM

Exclusion Criteria:

  • The participant has a detectable factor VIII inhibitor at screening, with a titer >= 0.4 Bethesda Unit (BU) (Nijmegen modification of the Bethesda Assay) measured at the local and the central laboratory
  • The participant has a known hypersensitivity to mouse or hamster proteins
  • The participant is participating in another investigational drug study within 30 days prior to screening
  • The participant is identified by the investigator as being unable or unwilling to cooperate with study procedures

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

Advate rAHF-PFM

Recombinate rAHF

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
Incremental Recovery. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
Increase in factor VIII concentration from pre- to 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.
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
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
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.
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.
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.
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 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 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 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 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).
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
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
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
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

Full Information

First Posted
April 22, 2008
Last Updated
April 28, 2021
Sponsor
Baxalta now part of Shire
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1. Study Identification

Unique Protocol Identification Number
NCT00666406
Brief Title
Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A
Official Title
Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A: a Phase IV, Prospective, Randomized, Controlled, Cross-over, Single Center Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
March 31, 2008 (Actual)
Primary Completion Date
February 18, 2009 (Actual)
Study Completion Date
February 18, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxalta now part of Shire

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemophilia A

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Advate rAHF-PFM
Arm Title
2
Arm Type
Active Comparator
Arm Description
Recombinate rAHF
Intervention Type
Drug
Intervention Name(s)
Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM)
Other Intervention Name(s)
Advate rAHF-PFM, Recombinant Protein-Free Factor VIII (rAHF-PFM)
Intervention Description
Infusion of 50 +/- 5 IU/kg bodyweight
Intervention Type
Drug
Intervention Name(s)
Recombinant Factor VIII (rAHF)
Other Intervention Name(s)
Recombinate rAHF, Antihemophilic Factor (Recombinant)
Intervention Description
Infusion of 50 +/- 5 IU/kg bodyweight
Primary Outcome Measure Information:
Title
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)
Description
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
Title
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)
Description
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
Title
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)
Description
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
Title
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)
Description
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
Secondary Outcome Measure Information:
Title
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)
Description
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
Time Frame
0-30 minutes before infusion up to 48 hours post-infusion
Title
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)
Description
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
Title
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)
Description
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
Title
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)
Description
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
Title
Systemic Clearance (Cl). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
Description
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
Title
Systemic Clearance (Cl). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
Systemic Clearance (Cl). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
Systemic Clearance (Cl). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
Maximum Plasma Concentration (C-max). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
Description
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
Title
Maximum Plasma Concentration (C-max). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
Maximum Plasma Concentration (C-max). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
Maximum Plasma Concentration (C-max). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
Terminal Half-life. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
Description
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
Title
Terminal Half-life. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
Terminal Half-life. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
Terminal Half-life. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
Incremental Recovery. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
Description
Increase in factor VIII concentration from pre- to post-infusion.
Time Frame
0-30 minutes before infusion up to 48 hours post-infusion
Title
Incremental Recovery. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
Incremental Recovery. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
Increase in factor VIII concentration from pre- to post-infusion
Time Frame
0-30 minutes before infusion up to 48 hours post-infusion
Title
Incremental Recovery. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
Increase in factor VIII concentration from pre- to post-infusion
Time Frame
0-30 minutes before infusion up to 48 hours post-infusion
Title
Mean Residence Time (MRT). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
Description
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
Title
Mean Residence Time (MRT). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
Mean Residence Time (MRT). FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
Mean Residence Time (MRT). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
Time to Reach the Maximum Plasma Concentration (Tmax). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
Description
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
Title
Time to Reach the Maximum Plasma Concentration (Tmax). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
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)
Description
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
Title
Time to Reach the Maximum Plasma Concentration (Tmax). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
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
Title
Volume of Distribution at Steady State (Vss). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)
Description
Computed as weight-adjusted Clearance * Mean Residence Time
Time Frame
0-30 minutes before infusion up to 48 hours post-infusion
Title
Volume of Distribution at Steady State (Vss). Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
Computed as weight-adjusted Clearance (CL) * Mean Residence Time
Time Frame
0-30 minutes before infusion up to 48 hours post-infusion
Title
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)
Description
Computed as weight-adjusted CL * Mean Residence Time
Time Frame
0-30 minutes before infusion up to 48 hours post-infusion
Title
Volume of Distribution at Steady State (Vss). FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)
Description
Computed as weight-adjusted CL * Mean Residence Time
Time Frame
0-30 minutes before infusion up to 48 hours post-infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent obtained from participant or legally authorized representative 15-60 years old Factor VIII level < 1% as documented by previously measured factor VIII and genotyping Previously treated with factor VIII concentrate(s) for a minimum of at least 150 exposure days (as documented by the study site investigator) prior to study entry Observed decrease of efficacy by subject and/or treating physician after being switched from Recombinate rAHF to Advate rAHF-PFM Exclusion Criteria: The participant has a detectable factor VIII inhibitor at screening, with a titer >= 0.4 Bethesda Unit (BU) (Nijmegen modification of the Bethesda Assay) measured at the local and the central laboratory The participant has a known hypersensitivity to mouse or hamster proteins The participant is participating in another investigational drug study within 30 days prior to screening The participant is identified by the investigator as being unable or unwilling to cooperate with study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
City
Bonn
ZIP/Postal Code
53127
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A

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