Alphanate in Immune Tolerance Induction Therapy

Exclusion Criteria

• •The subject has acquired factor VIII (FVIII) deficiency.
• •The subject has previously received ITI treatment.
• •The subject has a recent (within 1 month) history of central line infection at the time of Screening.
• •The subject has a high risk of cardiovascular, cerebrovascular, or thromboembolic event as judged by the investigator.
• •The subject is currently undergoing treatment with immunosuppressive drugs (eg, systemic corticosteroids), azathioprine, cyclophosphamide, high dose immunoglobulin, interferon, or the use of a protein A column or plasmapheresis and is unwilling to discontinue these treatments starting at the screening visit.
• •The subject has a known infection with human immunodeficiency virus (HIV) or has clinical signs and symptoms consistent with current HIV infection.
• •The subject has a known previous infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) or has clinical signs and symptoms consistent with current HBV or HCV infection.
• •The subject has significant proteinuria, has a history of acute renal failure or severe renal impairment (blood urea nitrogen or creatinine \>2 times the upper limit of normal), or is receiving dialysis at Screening.
• •The subject has a value of aspartate transaminase or alanine aminotransferase \>2 times the upper limit of normal at Screening.
• •The subject has clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place the subject at undue medical risk.
• •The subject has a history of anaphylaxis or severe systemic reaction to any plasma derived or other blood products.