Phase 3 Study for Efficacy and Safety Outcomes Data in Japanese Patients With Severe Hemophilia A

Inclusion Criteria: * Japanese males ≥18 years of age with HA and endogenous FVIII activity levels \<1 IU/dL as evidenced by medical history, at the time of signing the informed consent * Must have been on prophylactic FVIII replacement therapy for at least 12 months prior to study entry. High-quality, well-documented historical data concerning bleeding episodes and FVIII usage over the previous 12 months must be available. * Treated/exposed to FVIII concentrates for a minimum of 150 exposure days. * Willing and able to provide written, signed informed consent after the nature of the study has been explained and prior to any study-related procedures. * No previous documented history of a detectable FVIII inhibitor, and results from a Bethesda assay or Bethesda assay with Nijmegen modification of less than 0.6 Bethesda Units (BU) or less than 1.0 BU for laboratories with a historical lower sensitivity cutoff for inhibitor detection of 1.0 BU on 2 consecutive occasions at least 1 week apart within the past 12 months (at least 1 of which should be tested at the central laboratory). * Sexually active participants must agree to use an acceptable method of effective contraception * Willing to abstain from alcohol consumption for at least the first 52 weeks following BMN 270 infusion. Exclusion Criteria: * Detectable pre-existing antibodies to the AAV5 capsid. * Any evidence of active infection or any immunosuppressive disorder, except for human immunodeficiency virus (HIV) infec…