Study to Evaluate the Efficacy and Safety of PF-07055480 / Giroctocogene Fitelparvovec Gene Therapy in Moderately Severe to Severe Hemophilia A Adults

Main inclusion Criteria

• Males who have been followed on routine Factor VIII prophylaxis therapy during the lead-in study (C0371004) and have > = 150 documented exposure days to a Factor VIII protein product

• Moderately severe to severe hemophilia A (Factor VIII activity < =1%)

• Suspension of FVIII prophylaxis therapy post study drug infusion

Main exclusion Criteria

• Anti-AAV6 neutralizing antibodies

• History of inhibitor to Factor VIII

• Laboratory values at screening visit that are abnormal or outside acceptable study limits

• Significant and/or unstable liver disease, biliary disease, significant liver fibrosis

• Conditions associated with increased thromboembolic risk such as inherited or acquired thrombophilia, or a history of thrombotic events

• Planned surgical procedure requiring Factor VIII surgical prophylactic factor treatment 12 months from screening visit

• Active hepatitis B or C

• Serological evidence of human immunodeficiency virus HIV-1 or HIV-2 with Cluster of Differentiation 4 positive (CD4+) cell count ≤200 mm3 and/or viral load >20 copies/mL