A 24-month study evaluating physical activity and joint health in patients 12 years and older, with severe haemophilia A treated once weekly with efanesoctocog alfa.

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• The presence of any of the following will exclude a patient from inclusion in the study: 1. Medical conditions 1.1. Any concurrent clinically significant liver disease that, in the opinion of the Investigator, would make the patient unsuitable for enrolment. This may include, but is not limited to cirrhosis, portal hypertension, hepatic encephalopathy and acute hepatitis 1.2. Serious musculoskeletal and/or neurological impairment limiting the mobility and the physical ability to a degree that makes the patient unsuitable for the study as judged by the investigator 1.3. Serious active bacterial or viral infection (other than chronic hepatitis or HIV) present within 30 days of screening 1.4. Other known coagulation disorder(s) in addition to haemophilia A 1.5. History of hypersensitivity or anaphylaxis associated with any FVIII product 1.6. History of a positive inhibitor test defined as ≥0.6 BU/mL, or any value greater than or equal to the lower sensitivity cut-off for laboratories with cut-offs for inhibitor detection between 0.7 and 1.0 BU/mL, or clinical signs or symptoms of decreased response to FVIII administrations. Family history of inhibitors will not exclude the patient. 1.7. Positive inhibitor result (assessed by central laboratory), defined as ≥0.6 BU/mL at screening or baseline (see section 6.6.6.1). 1.8. Abnormal renal function, defined as serum creatinine >2.0 mg/dL taken at screening 1.9. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 x upper limit of normal (ULN), taken at screening 1.10. Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
• 2. Prior therapy 2.1. Vaccination within 15 days prior to the screening visit and during the run-in period 2.2. Treatment with acetylsalicylic acid within 2 weeks prior to screening 2.3. Treatment with NSAIDs above the maximum dose specified in the prescribing information within 2 weeks prior to screening 2.4. Systematic treatment within 12 weeks prior to screening with chemotherapy and/or other immunosuppressive drugs (except for the treatment of HCV or HIV). Use of corticosteroids is allowed, except for systemic corticosteroid treatment given daily or alternate days for >14 days. Local, topical, and/or inhaled steroid use is permitted
• 3. Prior clinical study experience 3.1. Previous enrolment in this study; patients who fail screening may re-screen (one time) 3.2. Treatment with an investigational product within 30 days or 5.5 half-lives prior to screening, whichever is longer. For investigational products with a pharmacodynamic effect that persists longer than the half-life, the maximal pharmacodynamic effect must return to baseline prior to screening.
• 4. Others 4.1. Major surgery within 12 weeks prior to screening or planned major orthopaedic surgery to occur during the study 4.2. Patients not suitable for participation, whatever reason, as judged by the investigator, including medical or clinical conditions, or patients potentially at risk of noncompliance to study procedures. 4.3. Patients are dependent on the sponsor or investigator (in conjunction with Section 1.61 of the ICH-GCP Ordinance E6) 4.4. Patients are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals 4.5. At baseline visit, patients who have not been compliant in using the activity tracker. For minimum requirements see section 6.4.6.2