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

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.