BAX 326 (Recombinant Factor IX): Evaluation of Safety, Immunogenicity, and Hemostatic Efficacy in Previously Treated Patients With Severe (FIX Level < 1%) or Moderately Severe (FIX Level <= 2%) Hemophilia B - A Continuation Study

CompletadoFase 3ClinicalTrials.gov

ID: NCT01286779Tipo: INTERVENTIONALInicio: 12 de abr de 2011Fin estimado: 29 de jun de 2017

Traducción no disponible, mostrando original

Resumen

The purpose of this BAX 326 Continuation Study is to further investigate incremental recovery over time, the hemostatic efficacy, the safety, immunogenicity, and health-related quality of life (HR QoL) of BAX 326 in previously treated patients (PTPs) with severe and moderately severe hemophilia B who participated in BAX 326 pivotal study 250901 or BAX 326 pediatric study 251101.

Elegibilidad

Edad máxima: 65 YearsSexo: ALL

Criterios de inclusión

Subject and/or legal representative has/have voluntarily provided signed informed consent
Subject has completed Baxter clinical study 250901 (pivotal study) or Baxter clinical study 251101 (pediatric study)
Subject was 12 to 65 years old at the time of screening for Study 250901 or \< 12 years old at the time of screening for Study 251101
Subject 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
Subject has not developed an inhibitory FIX antibody during Baxter Pivotal Study 250901 or Pediatric Study 251101

Criterios de exclusión

Subject received factor IX product(s) other than BAX 326 upon completion of Baxter Pivotal Study 250901 or Pediatric Study 251101
Subject has been diagnosed with an acquired hemostatic defect other than hemophilia B
For subjects transferring from Pivotal Study 250901: Subject's weight is \< 35 kg or \> 120 kg
Subject is planned to take part in any other clinical study, with the exception of BAX 326 Surgery study as described in this protocol, during the course of the Continuation Study

Intervenciones

biological

BAX 326 (Recombinant factor IX)

The treatment with BAX 326 will be at the discretion of the investigator and will consist of either twice weekly prophylactic treatment with 50 IU/kg, modified prophylaxis, or on-demand treatment.

Ubicaciones

Instituto de Hematología y Medicina Clíncia Rubén Dávoli

Rosario, Argentina

Patrocinadores

PrincipalBaxalta now part of Shire

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