Status:
COMPLETED
Prophylaxis 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
7-65 years
Phase:
PHASE4
Brief Summary
The primary purpose of this randomized, two-arm parallel clinical study in 66 previously treated patients with severe or moderately severe hemophilia A is to compare the rate of bleeding episodes for ...
Eligibility Criteria
Inclusion
- The subject has severe or moderately severe hemophilia A as defined by a baseline factor VIII level \<= 2% of normal, as tested at screening
- 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 7 to 65 years of age
- The subject has a Karnofsky performance score \> (greater than) 60
- The subject is human immunodeficiency virus negative (HIV-) or is HIV+ with a CD4 count \>= 400 cells/mm³ (CD4 count determined at screening, if necessary)
- The subject has been on a documented on-demand treatment regimen for at least 12 months immediately prior to enrollment
- The subject has a documented history (e.g. in medical charts or dispensing information, or signed investigator statement) of at least 8 joint hemorrhages in the 12 months immediately prior to enrollment
- The subject resides within the coverage area of the mobile compliance device; coverage area will be determined at screening
- The subject or the subject's legally authorized representative has provided written informed consent
Exclusion
- The subject has a known hypersensitivity to factor VIII concentrates or mouse or hamster proteins
- The subject has a history of factor VIII inhibitors with a titer \>= 0.6 BU (by Bethesda or Nijmegen assay) at any time prior to screening
- The subject has a detectable factor VIII inhibitor at screening, with a titer \>= 0.4 BU (by Nijmegen Assay) in the 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 been treated during the last sixty (60) days prior to or is being treated at screening/enrollment with an immunomodulating drug.
- The subject has participated in another investigational study within thirty (30) days of enrollment
- The subject has previously participated in a clinical study with rAHF-PFM
- The subject's clinical condition may require a major surgery (defined as moderate to critical risk and perioperative blood loss ≥ 500 mL) during the period of the subject's participation in the study
- The subject is female of childbearing potential with a positive pregnancy test
Key Trial Info
Start Date :
January 4 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 16 2010
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT00243386
Start Date
January 4 2006
End Date
June 16 2010
Last Update
May 19 2021
Active Locations (29)
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1
Los Angeles, California, United States
2
Chicago, Illinois, United States
3
Indianapolis, Indiana, United States
4
Minneapolis, Minnesota, United States