Patient inclusion and exclusion criteria
Patient inclusion criteria
- Male patients
- No age limits
- Haemophilia A (all severities)
- Inhibitor titre > 0.6 BU/ml with clinical relevance (i.e reduced IVR and/or t 1/2)
- ITI for the frst time or earlier ITI failure
- ITI according to the Bonn protocol recommended, but ITIs according to other therapy regimens also included
- Patients with the ability to comply with the ITI and study requirements (e.g. regular visits at the treating centre)
- Signed informed consent of the patient or legal guardians
Patient exclusion criteria
- Congenital or acquired bleeding defects other than haemophilia A
- Concomitant immunological diseases
- History of hypersensitivity to blood products and / or FVIII concentrates