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

• Status: Completed
• Trial end date: 2009-02-18
• Target enrollment: 0
• Participant gender: All

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%).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baxalta now part of Shire; Baxalta US Inc.
• Treatments: Factor VIII

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