Hemophilia A

Inclusion Criteria

- Participants must ≥ 18 years of age inclusive, at the time of signing the informed consent.
- Participants with severe hemophilia A (FVIII: C<1%)
- PTPs (Previously treated patients) (≥150 ED (Exposure day)) on prophylaxis treatment before enrollment
- Participants who are immunocompetent. If human immunodeficiency virus (HIV)
positive, cluster of differentiation 4 (CD4)+ lymphocyte count >200/mm*3
- Participants who are willing to complete an eDiary
- Male participants
- Capable of giving signed informed consent

Exclusion Criteria

- Any other inherited or acquired bleeding disorder in addition to Hemophilia A.
- Platelet count < 100,000/mm*3
- Creatinine > 2x upper limit of normal
- AST or ALT > 5x upper limit of normal (AST: aspartate aminotransferase; ALT: alanine aminotransferase)
- The participant has a planned major surgery. 
- The participant is currently participating in another investigational drug study, or has participated in a clinical study involving an investigational drug within 30 days of signing informed consent or previous treatment in a clinical phase III study with BAY 94-9027 (now marketed as Jivi).
- Current evidence (by central laboratory) or history of inhibitor to FVIII with a titer ≥ 0.6 Bethesda unit (BU).
- Known hypersensitivity to the drug substance, excipients, or mouse or hamster protein.