Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A
Condition: Severe Hemophilia A
MeSH terms: Hemophilia A
Intervention: Alphanate SD/HT
Intervention description: Plasma-derived preparation of Factor VIII
Intervention MeSH terms: Factor VIII
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: Male
Minimum age: 6 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Hemophilia A; Plasma-derived treatment; Factor VIII; Inhibitor

Summary:

      The purpose of this study is to determine the immunologic and overall safety associated with
      long-term use of Alphanate in subjects diagnosed with severe hemophilia A (Factor VIII:C less
      than 0.01 IU/ml), who have been previously treated with plasma-derived Factor VIII products
      other than Alphanate and who have no history of developing either antibody inhibitors to
      Factor VIII or nonspecific inhibitors of coagulation.
    

Eligibility criteria:

        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).