Brief Title
BAX 326 (rFIX) Continuation Study
Official Title
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
Brief Summary
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Adverse Events Possibly or Probably Related to the Investigational Product
Secondary Outcome
Treatment of Bleeding Episodes: Number of Infusions Per Bleeding Episode Required Until Bleed Resolution
Condition
Hemophilia B
Intervention
BAX 326 (Recombinant factor IX)
Study Arms / Comparison Groups
BAX 326
Description:
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
117
Start Date
April 12, 2011
Completion Date
June 29, 2017
Primary Completion Date
June 29, 2017
Eligibility Criteria
Main Inclusion Criteria: - 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 Main Exclusion Criteria: - 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
Gender
All
Ages
N/A - 65 Years
Accepts Healthy Volunteers
No
Contacts
Study Director, ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT01286779
Organization ID
251001
Secondary IDs
2010-022726-33
Responsible Party
Sponsor
Study Sponsor
Baxalta now part of Shire
Study Sponsor
Study Director, Study Director, Takeda
Verification Date
April 2021