Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis

Open label, prospective, non-interventional, single arm study in patients receiving KOVALTRY as prophylaxis therapy.

Inclusion criteria

• Male patients diagnosed with moderate to severe hemophilia A (≤ 5% FVIII:C (Factor VIII Coagulant activity))
• Any age
• ≥ 50 exposure days (EDs) to any FVIII product
• Patients with or without history of inhibitors

• Patient with previous history of inhibitors, with at least 2 consecutive negative inhibitor tests and on standard prophylaxis therapy for at least 1 year prior to study entry
• No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor

• Evidence of FVIII inhibitor as measured by the Nijmegen-modified Bethesda assay [<0.6 Bethesda units (BU/mL)] or Bethesda assay [< 1.0 BU/mL] in 2 on consecutives samples
• Documented or clinical suspicion of shortened FVIII half-life (< 6 hrs)
• Currently on or plan to start prophylaxis therapy with KOVALTRY
• Written informed consent

Exclusion criteria

• Patients participating in an investigational program with interventions outside of routine clinical practice
• Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A
• Patients on Immune Tolerance Induction (ITI) treatment at the time of enrollment