Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A

Inclusion Criteria: * Male. * At least 6 years of age and not more than 65 years of age. * Signed and dated Informed Consent Form and Patient Authorization for Release of Information approved by the appropriate Institutional Review Board (IRB) prior to screening and enrollment. If the subject is a minor (i.e., less than 18 years of age) both he and his parent or legal guardian must sign and date the informed consent. * Diagnosis of severe hemophilia A. * Levels of Factor VIII less than 0.01 IU/mL. * Treatment with cryoprecipitate, Factor VIII concentrates, and/or whole blood, for at least 150 cumulative exposure days (CEDs) prior to enrollment. * No treatment with cryoprecipitate, Factor VIII concentrate, or any other blood product, for at least 72 hours prior to screening. * No previous diagnosis with inhibitors to Factor VIII at any detectable titer. * Subjects must never have been diagnosed with nonspecific inhibitors of coagulation. * Negative test for the presence of Factor VIII inhibitors at screening and enrollment. * CD4 counts greater than or equal to 400 cells/µL. * Vaccination against hepatitis A and hepatitis B, or evidence of antibodies against hepatitis A and hepatitis B. (A subject who has no prior immunity against hepatitis A will be offered a course of vaccination for hepatitis A). * Karnofsky Performance Score of at least 50. Exclusion Criteria: * Any immunosuppressive medications including intravenous immunoglobulins at the time of enrollment. * Clinical…