Hemophilia APhase 4NCT00666406
Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A
A Phase 4 study testing Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) and Recombinant Factor VIII (rAHF) in people with Hemophilia A, run by Baxalta now part of Shire at 1 site in Germany.
Trial 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%). Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) and Recombinant Factor VIII (rAHF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- 31 Mar 2008to 18 Feb 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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%).
- Conditions
- Hemophilia A
- Being tested
- Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM), Recombinant Factor VIII (rAHF)
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM)Drug
Also called Advate rAHF-PFM, Recombinant Protein-Free Factor VIII (rAHF-PFM)
Infusion of 50 +/- 5 IU/kg bodyweight
Recombinant Factor VIII (rAHF)Drug
Also called Recombinate rAHF, Antihemophilic Factor (Recombinant)
Infusion of 50 +/- 5 IU/kg bodyweight
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Advate rAHF-PFM Receives: Drug: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) |
| 2 | Active comparator | Recombinate rAHF Receives: Drug: Recombinant Factor VIII (rAHF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 0-30 minutes before infusion up to 48 hours post-infusion
Secondary outcomes (32)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0-30 minutes before infusion up to 48 hours post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2008 (estimated)
- Study start31 Mar 2008
- Primary completion18 Feb 2009
- Study completion18 Feb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666406
- Sponsor's protocol ID
- 060601
- Other IDs
- 2007-004834-18
- Status last verified
- Apr 2021
- First submitted
- 22 Apr 2008
- Last updated
- 19 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00666406
- Acronym / sponsor ID
- 060601
- Conditions
- Hemophilia A
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2008 (actual)
- Primary completion
- 18 Feb 2009 (actual)
- Study completion
- 18 Feb 2009 (actual)
- First posted
- 24 Apr 2008 (estimated)
- Results
- Posted 26 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM)Advate rAHF-PFM |
| 2 | Active comparator | Drug: Recombinant Factor VIII (rAHF)Recombinate rAHF |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM)Also: Advate rAHF-PFM, Recombinant Protein-Free Factor VIII (rAHF-PFM)Infusion of 50 +/- 5 IU/kg bodyweight | Drug | 1 |
| Recombinant Factor VIII (rAHF)Also: Recombinate rAHF, Antihemophilic Factor (Recombinant)Infusion of 50 +/- 5 IU/kg bodyweight | Drug | 2 |
Primary outcome
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)
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
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)
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
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)
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
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)
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.
32 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Time frame: 0-30 minutes before infusion up to 48 hours post-infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM) and Recombinant Factor VIII (rAHF) in people with Hemophilia A, run by Baxalta now part of Shire at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 0-30 minutes before infusion up to 48 hours post-infusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.