Safety and Efficacy Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients Undergoing Surgery
Safety and Efficacy Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Hemophilia A Patients Undergoing Surgery
The purpose of this study is to evaluate whether rAHF-PFM is safe and effective in the
 treatment of hemophilia A patients undergoing surgery.
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.