Brief Title
BAX 326 Surgery Study in Hemophilia B Patients
Official Title
BAX 326 (Recombinant Factor IX): A Phase 3 Prospective, Multicenter Study Evaluating Efficacy and Safety in Previously Treated Patients With Severe (FIX Level < 1%) or Moderately Severe (FIX Level 1-2%) Hemophilia B Undergoing Surgical or Other Invasive Procedures
Brief 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Intraoperative Hemostatic Efficacy
Condition
Hemophilia B
Intervention
Recombinant factor IX
Study Arms / Comparison Groups
BAX326 in Surgery
Description: BAX 326 (recombinant factor IX) in Surgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
30
Start Date
December 19, 2011
Completion Date
May 15, 2014
Primary Completion Date
May 15, 2014
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.
Gender
All
Ages
12 Years - 65 Years
Accepts Healthy Volunteers
No
Contacts
Study Director, ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT01507896
Organization ID
251002
Secondary IDs
2011-000413-39
Responsible Party
Sponsor
Study Sponsor
Baxalta now part of Shire
Study Sponsor
Study Director, Study Director, Shire
Verification Date
June 2019