Efficacy & Safety of REFACTO AF in Prophylaxis Treatment

Patients receiving standard prophylaxis treatment with ReFacto AF as determined by the inclusion criteria will be included in the study. During this observational study, patients diagnosed with severe hemophilia A, and starting or continuing prophylaxis with ReFacto AF as per local standard clinical care, will be observed for 12 months. Patients who received prophylaxis with another FVIII product and are scheduled to switch to ReFacto AF prophylaxis can also be enrolled. Physician decision to initiate or to continue ReFacto AF prophylaxis therapy will be independent and it will precede subjects' inclusion in the study. Also the physician decision to switch the prophylaxis with another FVIII product to ReFacto AF will be independent and it will precede subjects' inclusion in the study. Detailed information on hemophilia A history and previous hemophilia treatments will be collected at Baseline. The number of bleedings and their treatment, status of joints and the quality of life will be assessed at 3, 6, 9 and 12 months after ReFacto AF prophylaxis initiation.

ReFacto AF dosing and treatment duration are at the discretion of the investigator in accordance with local clinical practice and local labeling. All clinical or laboratory assessments in this study will be conducted as per current medical practice in management of hemophilia A without any study related procedures.

Inclusion Criteria:

1. Male subjects with severe hemophilia A (FVIII:C <1%)
2. Age from 1 to 18 years
3. Previously untreated patients (PUPs) or previously treated patients (PTPs) with factor VIII
4. No previous history of FVIII inhibitors
5. Legally authorized representatives of pediatric patients agree to provide written informed consent form
6. Patients who are scheduled by their hematologist to initiate prophylaxis with ReFacto AF or to continue previously initiated prophylaxis with ReFacto AF, including patients who are switching from prophylaxis with another FVIII product to ReFacto AF.

Exclusion Criteria:

1. Subject has known hypersensitivity to the active substance or any of the excipients.
2. Subject has known allergic reaction to hamster proteins
3. Presence of any bleeding disorder in addition to hemophilia A.
4. Treatment with any investigational agent or device within the past 30 days.
5. Any other contraindications according to Summary of Product Characteristics
6. Unsuitable to participate in study for any other reason as assessed by investigator