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 standard prophylaxis (20-40 IU/kg every 48 ± 6 hours; actual dose determined by the investigator) with that of alternate prophylaxis (20-80 IU/kg every 72 + 6 hours; actual dose determined by Baxter utilizing an algorithm and the patient''''s pharmacokinetic data). The rates of bleeding episodes for the on-demand regimen and the prophylaxis regimens will also be compared. Enrolled patients will be treated originally on demand for a period of 6 months and then they will be randomized into one of the prophylaxis arms. Prophylactic treatment will last for a period of 12 months +/- 2 weeks.

Condition	Intervention	Phase
Hemophilia A	Drug: Antihemophilic factor, recombinant, manufactured protein-free	Phase IV

Further study details as provided by Baxter BioScience:

Expected Total Enrollment:  66

Ages Eligible for Study:  7 Years   -   65 Years,  Genders Eligible for Study:  Male

Criteria

Inclusion Criteria:

• 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 under the care of the study site for at least 24 months prior to enrollment
• 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) of at least 12 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 Criteria:

• 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 30 days of enrollment
• The subject has previously participated in a clinical study with rAHF-PFM
• The subject’s clinical condition may require a moderate or major surgery (defined as intra-operative estimated blood loss greater than 500 mL) during the period of the subject’s participation in the study

Please refer to this study by ClinicalTrials.gov identifier  NCT00243386

Illinois
      Rush Presbyterian St. Lukes, Chicago,  Illinois,  60612,  United States
Massachusetts
      New England Hemophilia Center, Worcester,  Massachusetts,  01605,  United States
Minnesota
      Fairview University Hemophilia and Thrombosis Center, Minneapolis,  Minnesota,  55455,  United States
Nevada
      Hemophilia Treatment Center of Las Vegas, Las Vegas,  Nevada,  89109,  United States
New Jersey
      University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick,  New Jersey,  08901,  United States
New Mexico
      Ted R. Montoya HTC, Albuquerque,  New Mexico,  87131-5311,  United States
New York
      Mount Sinai School of Medicine, New York,  New York,  10029,  United States
Oklahoma
      Oklahoma Center for Bleeding Disorders, Oklahoma City,  Oklahoma,  73104,  United States
Pennsylvania
      The Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States
Virginia
      Children´s Hospital of the King´s Daughters, Norfolk,  Virginia,  23507,  United States
Austria
      General Hospital Vienna, Department for Internal Medicine, Vienna,  1090,  Austria
Czech Republic
      University Hospital Brno, Brno,  63900,  Czech Republic
      Institute of Haematology and Blood Transfusion, Prague,  128 20 Praha 2,  Czech Republic
      University Hospital Motol, Prague,  150 06,  Czech Republic
Greece
      Laikon General Hospital, Goudi, Athens,  11527,  Greece
Hungary
      National Haemophilia Centre, Budapest,  1135,  Hungary
      Clinics of Internal Medicine, Dept. of Hematology, Pecs,  7624,  Hungary
Italy
      University Hospital Florence, Florence,  50134,  Italy
      Centro Emofilia A. Bianchi, Milano,  20122,  Italy
Slovenia
      Center for Hemophilia, Ljubliana,  61104,  Slovenia
      SPS Interna klinika, Ljubliana,  1525,  Slovenia
Spain
      Hospital Carlos Haya, Malaga,  29010,  Spain
United Kingdom
      University Hospital Queen´s Medical Centre, Nottingham,  NG7 2UH,  United Kingdom
      University Hospital of Wales, Cardiff,  CF14 4XW,  United Kingdom

Study ID Numbers:  060201
Last Updated:  December 8, 2005
Record first received:  October 21, 2005
ClinicalTrials.gov Identifier:  NCT00243386
Health Authority: United States: Food and Drug Administration; Austria: Federal Ministry for Health and Women; Czech Republic: State Institute for Drug Control; Greece: Ministry of Health and Welfare; Hungary: National Institute of Pharmacy; Italy: Ministry of Health; Slovenia: Agency for Medicinal Products - Ministry of Health; Spain: Spanish Agency of Medicines; United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2006-01-10