Status:
COMPLETED
Dose-Response Study of Recombinant Factor VIII Manufactured Protein-Free (rAHF-PFM) in Patients With Hemophilia A
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Hemophilia A
Eligibility:
All Genders
12-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine the effect of 3 doses of ADVATE rAHF-PFM on initial recovery (% increase \[IU/dL\] per IU/kg infused) and major single-infusion pharmacokinetic parameters. Th...
Eligibility Criteria
Inclusion
- The subject has severe hemophilia A as defined by a baseline factor VIII activity \<1% of normal; tested at screening. (A minimum washout period of 3 days is required before the blood sample can be drawn to determine baseline factor VIII levels.)
- The subject has a documented history of at least 150 exposure days to factor VIII concentrates (either plasma-derived or recombinant).
- The subject is within 12 to 65 years of age.
- The subject has a Karnofsky performance score \>60.
- The subject is human immunodeficiency virus negative (HIV-) or HIV+ with CD4 count \>=400 cells/mm3 (CD4 count determined at screening, if necessary).
- The subject or subject´s legally authorized representative has provided written informed consent.
Exclusion
- The subject has a known hypersensitivity to mouse or hamster proteins or to factor VIII concentrates.
- The subject has a history of factor VIII inhibitors with titer \>=0.8 BU (Bethesda Assay) or \>=0.4 BU (Nijmegen modification of the Bethesda Assay) any time prior to screening.
- The subject has a detectable factor VIII inhibitor at screening, \>=0.4 BU (Nijmegen modification of the Bethesda Assay), in the Baxter central laboratory.
- The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) \>1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
- The subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (e.g. qualitative platelet defect or von Willebrand´s Disease).
- The subject has participated in another investigational study within 30 days of enrollment.
- The subject´s clinical condition may require a major or moderate surgery (estimated blood loss \>500 mL) during the period of participation in the study.
Key Trial Info
Start Date :
February 2 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00289536
Start Date
February 2 2006
End Date
April 1 2007
Last Update
June 10 2021
Active Locations (8)
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1
Little Rock, Arkansas, United States
2
Los Angeles, California, United States
3
Peoria, Illinois, United States
4
Iowa City, Iowa, United States