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 signs or symptoms of an infection, such as fever, chills or nausea during screening or enrollment.
• History of frequent reactions to Factor VIII concentrates (e.g., chills or headaches).
• Prior treatment with Alphanate® (Solvent-Detergent/ Heat-Treated).
• Immunocompromised (including HIV+ status or has an impaired immune system due to disease or treatment).