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

Inclusion Criteria:

- Participant requires an elective major or minor surgical, dental or other invasive
procedure (e.g. biopsy, endoscopy).

- Participant and/or legal representative has/have provided signed informed consent.

- Participant has severe hemophilia A (Factor VIII (FVIII) level <1%) as confirmed by
the central lab at screening or a documented FVIII activity level <1%.

- Participant was previously treated with FVIII concentrates with ≥150 documented
exposure days (EDs).

- Participant is currently receiving prophylaxis or on-demand therapy with FVIII
concentrate.

- Participant has a Karnofsky performance score of ≥60 at screening.

- Participant is human immunodeficiency virus negative (HIV-); or HIV+ with stable
disease and CD4+ count ≥200 cells/mm^3, as confirmed by central laboratory at
screening.

- Participant is Hepatitis C virus negative (HCV-) by antibody or PCR testing (if
positive, antibody titer will be confirmed by PCR), as confirmed by central laboratory
at screening; or HCV+ with chronic stable hepatitis as assessed by the investigator.

- Participant is willing and able to comply with the requirements of the study protocol.

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.