The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the treatment of hemophilia A patients undergoing surgery.

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

Further Study Details: 

Ages Eligible for Study:  5 Years and above,  Genders Eligible for Study:  Male

Criteria

Inclusion Criteria:

• Age >= 5 years
• The subject has severe or moderately severe hemophilia A defined by a baseline factor VIII level <= 2% of normal documented at screening or historically (e.g., at hemophilia diagnosis)
• Subjects may enroll regardless of their serologic status for human immunodeficiency virus (HIV-1) and hepatitis C virus (HCV)
• The subject requires a surgical, dental or other invasive procedure--either elective or emergency
• The subject has a history of at least 150 exposure days for all other factor VIII products (as estimated by the study site investigator) prior to study entry
• The subject has a life expectancy of at least 28 days from the day of surgery
• The subject has been informed of the nature of the study, agreed to its provisions, and signed and dated the informed consent form approved by the appropriate IRB/IEC and Baxter BioScience

Exclusion Criteria:

• The subject has a detectable inhibitor to factor VIII in the local hemostasis laboratory at the investigative site at the time of enrollment
• The subject has a history of inhibitor to factor VIII > 1.0 BU. Note: If the subject has a history of an inhibitor titer > 1.0 BU at any time prior to enrollment but demonstrated expected clinical responses to conventional doses of factor VIII therapy, the subject may enroll
• The subject has known hypersensitivity to Recombinate
• The subject is currently participating in another investigational drug study, or has participated in any clinical trial involving an investigational drug within 30 days of study entry
• The subject has clinical and/or laboratory evidence of abnormal hemostasis from causes other than hemophilia A (e.g., late-stage chronic liver disease, immune thrombocytopenic purpura, disseminated intravascular coagulation)
• The subject is identified by the investigator as being unable or unwilling to cooperate with study procedures.

California
      Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology, Los Angeles,  California,  90027,  United States
Georgia
      Children´s Healthcare of Atlanta Blood Bank, Atlanta,  Georgia,  30322,  United States
Indiana
      Indiana Hemophilia & Thrombosis Center, Indianapolis,  Indiana,  46260,  United States
Iowa
      University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics, Iowa City,  Iowa,  52242,  United States
Massachusetts
      Brigham and Women´s Hospital, Hematology Division, Boston,  Massachusetts,  02115,  United States
Michigan
      Michigan State University, East Lansing,  Michigan,  48824,  United States
New York
      Mt. Sinai Medical School, Hemophilia Comprehensive Care Center, New York,  New York,  10029,  United States
Ohio
      Children´s Hospital Medical Center Pharmacy, Hemophilia Treatment Center, Cincinnati,  Ohio,  45229,  United States
Pennsylvania
      Hemophilia Center of Western Pennsylvania, Pittsburgh,  Pennsylvania,  15213-4306,  United States
Washington
      Puget Sound Blood Center, Seattle,  Washington,  98104-1256,  United States

Study chairs or principal investigators

Amy Shapiro, MD,  Principal Investigator,  Indiana Hemophilia & Thrombosis Center   

Study ID Numbers:  069902
Last Updated:  September 10, 2005
Record first received:  September 8, 2005
ClinicalTrials.gov Identifier:  NCT00157105
Health Authority: United States: Food and Drug Administration; Austria: Federal Ministry for Health and Women; Belgium: Directorate general for the protection of Public health: Medicines; Germany: Paul-Ehrlich-Institut; Italy: Ministry of Health; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-09-13