- Male subjects records, including newborns.
- No prior exposure to factor products or any blood products.
- Presence of any bleeding disorder in addition to hemophilia A.
- Treatment with any investigational agent or device within the past 30 days.
- Any condition(s) that compromises the ability to collect study-related observations,
or that poses a contraindication to study participation (these conditions include, but
are not limited to, inadequate medical history to assure study eligibility; and
expectation of poor adherence to study requirements).