Status:
COMPLETED
Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Hemophilia A
Eligibility:
All Genders
15-60 years
Phase:
PHASE4
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 (fac...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 31 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2009
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT00666406
Start Date
March 31 2008
End Date
February 18 2009
Last Update
May 19 2021
Active Locations (1)
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1
Bonn, Germany, 53127