BAX 326 (rFIX) Continuation Study

Baxalta

Status and phase

Completed

Phase 3

Conditions

Hemophilia B

Treatments

Biological: BAX 326 (Recombinant factor IX)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01286779

2010-022726-33 (EudraCT Number)

251001

Details and patient eligibility

About

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.

Enrollment

117 patients

Sex

All

Ages

Under 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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