1. Severe (FVIII: C
[at least 4 spontaneous bleeds clinically documented during a 6 months period] and
without inhibitors) male subjects with hemophilia A receiving routine prophylaxis
- From 2 to 18 years;
- Subjects above 18 years who began routine prophylaxis treatment in childhood (and
were part of the national prophylaxis program when turned 18 years).
3. Previously treated patients (PTPs) with hemophilia A. Previously treated patient (PTP)
is considered in this study as a subject who has at least 50 exposure days to any
FVIII product. An exposure day (ED) is a 24-hour period during which a dose of FVIII
concentrate has been administered, irrespective of size and frequency.
4. No history and no current FVIII inhibitor defined as a titer ≥0.6 BU/mL or any
measured Bethesda inhibitor titer greater than the upper limit of normal for the
laboratory performing the assay.
5. Subjects who are scheduled by their treating physician to initiate prophylaxis with
ReFacto AF or to continue previously initiated prophylaxis with ReFacto AF, and
subjects who are switching from prophylaxis with another FVIII product to ReFacto AF.
6. Evidence of a personally signed and dated informed consent and assent (for children
6-17 years of age) document indicating that the subject (or a legally acceptable
representative) has been informed of all pertinent aspects of the study.
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 (SPC).
6. Unsuitable to participate in study for any other reason as assessed by the
7. Subjects (or a legally acceptable representative) not able to understand study
documents and study procedure.