Overview

This trial is active, not recruiting.

Condition hemophilia b
Treatment bax 326 (recombinant factor ix)
Phase phase 3
Sponsor Baxalta US Inc.
Start date April 2011
End date June 2017
Trial size 117 participants
Trial identifier NCT01286779, 2010-022726-33, 251001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.

Primary Outcomes

Measure
Adverse events possibly or probably related to the investigational product
time frame: Assessed (based on patient diary) every 3 months until study completion

Eligibility Criteria

Male or female participants up to 65 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Baxalta US Inc..