BAX 326 Surgery Study in Hemophilia B Patients

Baxalta

Status and phase

Completed

Phase 3

Conditions

Hemophilia B

Treatments

Biological: Recombinant factor IX

Study type

Interventional

Funder types

Industry

Identifiers

NCT01507896

2011-000413-39 (EudraCT Number)

251002

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

12 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.