This is a non-interventional, multicenter, observational, international study in male persons with haemophilia A who have developed inhibitors to any replacement coagulation factor VIII (FVIII) product. The purpose of the study is to capture different approaches in the management of persons with haemophilia A and FVIII inhibitors, document current immune tolerance induction approaches, and evaluate the efficacy and safety of immune tolerance induction, including the combination of FVIII and emicizumab. Patients will be assigned to 1 of 3 groups based on the treatments they receive, and may switch to another group if their treatment is changed. Participants will be followed after a maximum observational period of 5 years.
Sex
MALE
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A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Proportion of participants achieving inhibitor titer < 0.6 Bethesda units (BU)/mL L for at least 2 consecutive measurements
Timeframe: Up to 5 years
Proportion of participants achieving FVIII recovery ≥ 66% of the predefined reference value of 1.5% IU/kg body weight (Groups 1 and 2)
Timeframe: Up to 5 years
Proportion of participants achieving FVIII half-life ≥ 6 h (Groups 1 and 2)
Timeframe: Up to 5 years
Annualized bleeding rate
Timeframe: Up to 5 years