BAX 326 Surgery Study in Hemophilia B Patients
Condition: Hemophilia B
MeSH terms: Hemophilia A; Hemophilia B
Intervention: Recombinant factor IX
Intervention description: Following a loading dose with BAX326, participants will receive BAX326 as a bolus infusion. The treatment regimen will be determined by the intensity and duration of the hemostatic challenge and the institution´s standard of care. The dose will be tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 12 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to assess the hemostatic efficacy and safety of BAX 326 in
      subjects with severe (FIX level < 1%) or moderately severe (FIX level 1-2%) hemophilia B
      undergoing major or minor elective or emergency surgical, dental or other invasive
      procedures.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Participant and/or legal representative has/have voluntarily provided signed informed
             consent.

          -  Participant has severe (FIX level < 1%) or moderately severe (FIX level 1-2%)
             hemophilia B (based on the one stage activated partial thromboplastin time (aPTT)
             assay), as tested at screening at the central laboratory.

          -  Participant requires surgery

          -  Participant has previously been treated with plasma-derived and/or recombinant FIX
             concentrate(s) for a minimum of 150 exposure days

          -  Participant has no evidence of a history of FIX inhibitors

          -  Participant is immunocompetent as evidenced by a CD4 count ≥ 200 cells/mm3.

          -  Participant is human immunodeficiency (HIV) negative or is HIV+ with a viral load <
             200 particles/μL ~ < 400,000 copies/mL.

        Main Exclusion Criteria:

          -  Participant has a history of FIX inhibitors with a titer ≥ 0.6 Bethesda Units (BU) (as
             determined by the Nijmegen modification of the Bethesda assay or the assay employed in
             the respective local laboratory) at any time prior to screening.

          -  Participant has a detectable FIX inhibitor at screening, with a titer ≥0.6 Bethesda
             Units (BU) as determined by the Nijmegen modification of the Bethesda assay in the
             central laboratory.

          -  Participant has a history of allergic reaction or evidence of an ongoing or recent
             thrombotic disease, fibrinolysis or disseminated intravascular coagulation (DIC).

          -  Known hypersensitivity to hamster proteins or recombinant furin.

          -  Evidence of an ongoing or recent thrombotic disease, fibrinolysis or disseminated
             intravascular coagulation (DIC).

          -  Abnormal renal function

          -  Severe chronic liver disease

          -  Active hepatic disease with ALT or AST levels > 5 times the upper limit of normal.

          -  Diagnosis of an iherited or acquired hemostatic defect other than hemophilia B.

          -  Platelet count < 100,000/mL.