Brief Title
Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A
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
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 (factor VIII level < 1%).
Study Phase
Phase 4
Study Type
Interventional
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)
Secondary Outcome
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)
Condition
Hemophilia A
Intervention
Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM)
Study Arms / Comparison Groups
1
Description: Advate rAHF-PFM
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
9
Start Date
March 31, 2008
Completion Date
February 18, 2009
Primary Completion Date
February 18, 2009
Eligibility 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
Gender
All
Ages
15 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
Study Director, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT00666406
Organization ID
060601
Secondary IDs
2007-004834-18
Responsible Party
Sponsor
Study Sponsor
Baxalta now part of Shire
Study Sponsor
Study Director, Study Director, Takeda
Verification Date
April 2021