Safety and Efficacy Study of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in 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.