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

Baxalta

Status and phase

Completed

Phase 4

Conditions

Hemophilia A

Treatments

Drug: Recombinant Factor VIII (rAHF)

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

Study type

Interventional

Funder types

Industry

Identifiers

NCT00666406

060601

2007-004834-18 (EudraCT Number)

Details and patient eligibility

About

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%).

Enrollment

9 patients

Sex

All

Ages

15 to 60 years old

Volunteers

No 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