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

CompletadoFase 3ClinicalTrials.gov

ID: NCT01507896Tipo: INTERVENTIONALInicio: 19 de dic de 2011Fin estimado: 15 de may de 2014

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 65 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

biological

Recombinant factor IX

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.

Ubicaciones

Instituto de Hematología y Medicina Clínica Rubén Dávoli

Rosario, Argentina

Patrocinadores

PrincipalBaxalta now part of Shire

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