Baxalta Manufacturing SARL

Primary Objectives: To evaluate the effectiveness of ADYNOVATE for prophylactic treatment of Chinese subjects with severe hemophilia A based on total ABR. Secondary Objectives: To evaluate the effectiveness of ADYNOVATE for prophylactic treatment based on ABR and etiology of bleeding site To evaluate the overall hemostatic effectiveness of ADYNOVATE for the treatment of non-surgical breakthrough bleeding events during the study period To evaluate the effectiveness of ADYNOVATE for perioperative bleeding management (if minor surgery is performed during the study period) To evaluate the safety of ADYNOVATE by evaluating AEs, serious AEs (SAEs), and clinically significant results of vital signs and clinical laboratory parameters To evaluate the safety and immunogenicity of ADYNOVATE based on the incidence of FVIII inhibitory antibodies and ADYNOVATE binding antibodies To evaluate the PK of ADYNOVATE in Chinese subjects