- Male and/or Female subjects with Hemophilia A.
- Subjects/parents/legal representatives must be able to comply with registry procedures
(informed consent/assent process, clinical visits, reporting of infusion and bleed
data, reporting of adverse events, etc).
- Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative, parent(s)/legal guardian) has
been informed of all pertinent aspects of the study.
- Presence of any other bleeding disorder in addition to hemophilia A.
- Treatment with immunomodulatory therapy (e.g., intravenous immunoglobulin, routine
systemic corticosteroids, cyclosporins, anti-TNF agents) within 30 days prior to study
entry or planned use for the duration of their study participation.
- Subjects with a past history of, or current factor VIII inhibitor. For
laboratory-based assessments, any Bethesda inhibitor titer greater than the
laboratory's normal range or ?0.6 BU/mL.
- Subjects with known hypersensitivity to the active substance or to any of the
excipients of Xyntha.
- Subjects with a known hypersensitivity to Chinese Hamster Ovary cell proteins.
- Unwilling or unable to follow the terms of the protocol.
- Any condition which may compromise the subject's ability to comply with and/or perform
study-related activities or that poses a clinical contraindication to study
participation (these conditions include, but are not limited to, inadequate medical
history to assure study eligibility; expectation of poor compliance in provision of
observations for study-related documentation), in the opinion of the Investigator.
- Participation in other studies involving investigational drug(s) (Phases 1-4) within
30 days before the current study begins and/or during study participation (exception
for studies on Xyntha).
- Subjects who are investigational site staff members directly involved in the conduct
of the study and their family members, site staff members otherwise supervised by the
Investigator, or subjects who are Pfizer employees directly involved in the conduct of
the study.