Phase 3 Efficacy and Safety Study of BAX 855 in Severe Hemophilia A Patients Undergoing Surgical Procedures
Condition: Hemophilia A
MeSH terms: Hemophilia A
Intervention: PEGylated Recombinant factor VIII (rFVIII)
Intervention description: Lyophilized powder and solvent for solution for injection
Intervention MeSH terms: Factor VIII; BAX 855
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Male
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to evaluate the efficacy and safety of BAX 855 in severe
      hemophilia A previously treated (PTP) males, 12 to 65 years of age who are undergoing
      elective surgical or other invasive procedures.
    

Eligibility criteria:

        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.