Study of Biostate for Treatment of Children With Hemophilia A Complicated by Antibody Development

Inclusion Criteria: * Male subjects diagnosed with haemophilia A (≤ 2% FVIII level in the absence of factor replacement, according to their medical history). * Age 28 days to \<12 years. * Subject is eligible for immune tolerance induction (ITI) therapy Exclusion Criteria: * The subject has received ITI previously. * Subjects with a historical peak inhibitor titre of ≥ 200 BU/mL. * Concomitant treatment with drugs with immunosuppressive side effects (eg, systemic corticosteroids), azathioprine, cyclophosphamide, high dose immunoglobulin or the use of a protein A column or plasmapheresis and interferons. * High risk of cardiovascular, cerebrovascular, or other thromboembolic events (excluding catheter thrombosis) as judged by the investigator. * Subjects who are human immunodeficiency virus (HIV)-1 or HIV-2 positive (as reported in the medical records or determined at screening).