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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2009-02-18

Brief Summary

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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%).

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Advate rAHF-PFM

Group Type EXPERIMENTAL

Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM)

Intervention Type DRUG

Infusion of 50 +/- 5 IU/kg bodyweight

2

Recombinate rAHF

Group Type ACTIVE_COMPARATOR

Recombinant Factor VIII (rAHF)

Intervention Type DRUG

Infusion of 50 +/- 5 IU/kg bodyweight

Interventions

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Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM)

Infusion of 50 +/- 5 IU/kg bodyweight

Intervention Type DRUG

Recombinant Factor VIII (rAHF)

Infusion of 50 +/- 5 IU/kg bodyweight

Intervention Type DRUG

Other Intervention Names

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Advate rAHF-PFM Recombinant Protein-Free Factor VIII (rAHF-PFM) Recombinate rAHF Antihemophilic Factor (Recombinant)

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No