Status:
COMPLETED
BAX 326 Surgery Study in Hemophilia B Patients
Lead Sponsor:
Baxalta now part of Shire
Conditions:
Hemophilia B
Eligibility:
All Genders
12-65 years
Phase:
PHASE3
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 min...
Eligibility Criteria
Inclusion
- Main
- 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
- 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.
Key Trial Info
Start Date :
December 19 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01507896
Start Date
December 19 2011
End Date
May 15 2014
Last Update
May 19 2021
Active Locations (14)
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1
Instituto de Hematología y Medicina Clínica Rubén Dávoli
Rosario, Argentina, 2000
2
Specialized Haematological Hospital "Joan Pavel"
Sofia, Bulgaria, 1233
3
Hospital Dr. Sotero del Rio
Santiago, Chile
4
Centro Medico Imbanaco
Cali, Colombia