Single-Arm Study To Evaluate The Efficacy and Safety of Valoctocogene Roxaparvovec in Hemophilia A Patients at a Dose of 4E13 vg/kg

Inclusion Criteria: 1. Males ≥ 18 years of age with hemophilia A and residual FVIII levels ≤ 1 IU/dL as evidenced by medical history. 2. Must have been on prophylactic FVIII replacement therapy for at least 12 months prior to study entry. 3. Treated/exposed to FVIII concentrates or cryoprecipitate for a minimum of 150 exposure days. 4. No previous documented history of a detectable FVIII inhibitor of less than 0.6 Bethesda Units (BU). Exclusion Criteria: 1. Detectable pre-existing antibodies to the AAV5 capsid. 2. Any evidence of active infection or any immunosuppressive disorder, including HIV infection. 3. Significant liver dysfunction, prior liver biopsy showing significant fibrosis, liver cirrhosis of any etiology or history of hepatic malignancy. 4. Evidence of any bleeding disorder not related to hemophilia A. 5. Active Hepatitis C. 6. Prior treatment with any vector/gene transfer agent.