Study to Test the Safety and How Well Patients With Severe Hemophilia A Respond to Treatment With BAY 2599023 (DTX 201), a Drug Therapy That Delivers a Healthy Version of the Defective Factor VIII Gene Into the Nucleus of Liver Cells Using an Altered, Non-infectious Virus (AAV) as a "Shuttle"

Exclusion Criteria

• •History of allergic reaction to any FVIII product.
• •Clinically relevant findings in the physical examination considered critical by the treating physician, including obesity with BMI \> 35 kg/m\*2
• •Current evidence of measurable inhibitor against factor VIII, prior history of inhibitors to FVIII protein or clinical history suggestive of inhibitor.
• •Evidence of active hepatitis B or C.
• •Currently on antiviral therapy for hepatitis B or C.
• •Significant underlying liver disease.
• •Serological evidence of HIV-1 or HIV-2 with CD4 counts ≤200/mm\*3; HIV+ and stable participants with CD4 count \>200/mm\*3 and undetectable viral load are eligible to enroll.
• •Detectable antibodies reactive with AAVhu37capsid.
• •Participant with another bleeding disorder that is different from hemophilia A (e.g., von Willebrand disease, hemophilia B).
• •Participated in a gene transfer trial within the last 52 weeks or in a clinical trial with an investigational product within the last 12 weeks.
• •Known or suspected hypersensitivity or allergic reaction to trial product(s) or related FVIII products or any component of BAY2599023 (DTX201), or a contraindication to prednisolone