Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures

Exclusion Criteria

• •Participant has detectable FVIII inhibitory antibodies (≥0.4 Bethesda Unit (BU) using the Nijmegen modification of the Bethesda assay) at screening as determined by the central laboratory or at any timepoint prior to screening (≥0.4 BU using the Nijmegen modification of the Bethesda assay or ≥0.6 BU using the Bethesda assay).
• •History of ongoing or recent thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).
• •Participant has a platelet count \<100 x 10\^9/L, as confirmed by central laboratory at screening.
• •Participant has severe renal impairment (serum creatinine \> 2.0 mg/dL), as confirmed by central laboratory at screening.
• •Participant has severe chronic hepatic dysfunction (eg ≥5 X upper limit of normal alanine aminotransferase (ALT), as confirmed by the central laboratory at screening, or a documented International Normalized Ratio (INR) \> 1.5).
• •Participant has a known hypersensitivity towards mouse or hamster proteins, polysorbate 80 or to PEG.
• •Participant is currently using or has recently (\< 30 days) used pegylated drugs (other than BAX 855) prior to study participation or is scheduled to use such drugs during trial participation.
• •Participant is currently participating in another clinical drug (other than BAX 855) or device study or use of another investigational product or device within 30 days prior to study entry.
• •Participant has a diagnosis of an inherited or acquired hemostatic defect other than hemophilia A.
• •Participant is currently receiving, or scheduled to receive during the course of the study, an immunomodulating drug (eg, systemic corticosteroid agent at a dose equivalent to hydrocortisone \>10 mg/day, or alpha interferon) other than anti-retroviral chemotherapy.
• •Participant has a clinically significant medical, psychiatric, or cognitive illness, or recreational drug/alcohol use that, in the opinion of the investigator, would affect participant safety or compliance.