A Study Evaluating Physical Activity and Joint Health in Severe Haemophilia A Patients ≥12 Years Treated Once Weekly With Efanesoctocog Alfa

Key Inclusion Criteria:

• Previous treatment for haemophilia A with any marketed recombinant and/orplasma-derived FVIII for at least 150 EDs.

• Having received prophylactic treatment with any marketed recombinant and/or plasmaFVIII or emicizumab per local label for at least 12 months preceding enrolment.

• Having 12 months documented pre-study treatment data regarding prophylactictreatment prescriptions and 6 months data on bleeding episodes prior to baselinevisit.

• Willingness and ability to complete training in the use of the study ePD and to usethe ePD in their own smartphone throughout the study.

• Willingness and ability to use the activity tracker provided by the sponsor tomeasure physical activity and heart rate.

• Be able and willing to administer efanesoctocog alfa intravenously at home.

Key Exclusion Criteria:

• Serious musculoskeletal and/or neurological impairment limiting the mobility and thephysical ability to a degree that makes the patient unsuitable for the study asjudged by the investigator.

• Other known coagulation disorder(s) in addition to haemophilia A.

• History and/or current positive inhibitor test defined as ≥0.6 BU/mL.

• Treatment with NSAIDs above the maximum dose specified in the prescribinginformation within 2 weeks prior to screening.

• Systematic treatment within 12 weeks prior to screening with chemotherapy and/orother immunosuppressive drugs.

• Treatment with an investigational product within 30 days or 5.5 half-lives prior toscreening, whichever is longer.

• Major surgery within 12 weeks prior to screening or planned major orthopaedicsurgery to occur during the study.

• At baseline visit, patients who have not been compliant in using the activitytracker.