Pharmacokinetic Comparison of Advate rAHF-PFM With Recombinate rAHF in Patients With Severe Hemophilia A
Information source: Baxter Healthcare Corporation
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemophilia A
Intervention: Recombinant Protein-Free Factor VIII (rAHF-PFM) (Drug); Recombinant Factor VIII (rAHF) (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Baxter Healthcare Corporation
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%).
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Area under the plasma concentration versus time curve from 0 to 48 hours (computed using the linear trapezoidal rule)
Eligibility
Minimum age: 15 Years.
Maximum age: 60 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Signed informed consent obtained from subject 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 subject has a detectable factor VIII inhibitor at screening, with a titer >= 0. 4
BU (Nijmegen modification of the Bethesda Assay) measured at the local and the central
laboratory
- The subject has a known hypersensitivity to mouse or hamster proteins
- The subject is participating in another investigational drug study within 30 days
prior to screening
- The subject is identified by the investigator as being unable or unwilling to
cooperate with study procedures
Locations and Contacts
University Clinic Bonn, Insititute of Experimental Hematology and Transfusion Medicine, Bonn 53127, Germany; Recruiting
Johannes Oldenburg, MD, Phone: +49-228-287-15176, Email: johannes.oldenburg@ukb.uni-bonn.de
Johannes Oldenburg, MD, Principal Investigator
Additional Information
Starting date: March 2008
Last updated: January 8, 2009
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