Clinical trial: Safety Study of Alphanate in Previously Treated Patients With Severe Hemophilia A (NCT00323856)

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).
Male
No healthy subjects accepted to join the trial.
Subject must be at least 6 Years old.
Subject must be at most 65 Years

Patient description (medical language): A 20-year-old man comes to the emergency due to bleeding after a tooth extraction.  The bleeding has persisted for approximately 30 minutes despite constant direct pressure.  He is a known case of Hemophilia type A treated with FVIII. Blood pressure is 95/60 mm Hg and pulse is 105/min. His weight is 70 Kg. Family history is positive for Hemophilia type A in his maternal uncle. He also has a lipoma on his left arm which he plans to remove surgically. His FVIII activity is 40%.

Patient description (patient's own words): I got my tooth extracted and I could not stop bleeding for 30 min. I'm a 20 yo dude but I have Hemophilia type A treated with FVIII. My blood pressure was 95/60 and my pulse 105/min. I'm 70 kg. My uncle on my mom's side also has type A hemophilia. I also have a fatty swelling on my left arm and I was supposed to remove it. My FVIII activity was 40%.

Does the patient match the trial criteria? Contradiction