- Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia A
(FVIII activity: more than 5%, 1-5%, or less than 1%, respectively)
- Subjects with previous exposure to FVIII replacement therapy
- If human immunodeficiency virus (HIV) positive, documented cluster of differentiation
(CD4) count more than 200/µL within 6 months of study entry
- Diagnosed with any bleeding disorder in addition to hemophilia A
- Current FVIII inhibitor or history of FVIII inhibitor (defined as positive result of
the reporting laboratory)
- Subject has no history of exposure to FVIII products (previously untreated patient
[PUP])
- Subject is currently utilizing primary FVIII prophylaxis
- Subjects anticipating elective surgery that may be planned to occur in the 6 months
following study entry
- Treated with immunomodulatory therapy within 30 days prior to study entry or planned
use for the duration of their study participation
- Participated in another investigational drug or device study within 30 days prior to
study entry or planned participation for the duration of their study participation
- Subjects with a known hypersensitivity to hamster protein
- Significant hepatic or renal impairment (alanine aminotransferase [ALT] and aspartate
aminotransferase [AST] >5 x upper limit of normal [ULN], bilirubin >2 mg/dL or serum
creatinine >1.25 x ULN)
- Prothrombin Time >1.5 x ULN
- Platelet count
- Pregnant or breastfeeding women
- 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, in the opinion of the Investigator or Sponsor