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BAX 326 (rFIX) Continuation Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Baxalta US Inc.
ClinicalTrials.gov Identifier:
NCT01286779
First received: January 26, 2011
Last updated: June 6, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention Phase
Hemophilia B Biological: BAX 326 (Recombinant factor IX) Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Baxalta US Inc.:

Primary Outcome Measures:
  • Adverse events possibly or probably related to the investigational product [ Time Frame: Assessed (based on patient diary) every 3 months until study completion ]
    Descriptive analysis


Enrollment: 117
Actual Study Start Date: April 12, 2011
Estimated Study Completion Date: June 30, 2017
Estimated Primary Completion Date: June 30, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BAX 326 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.

  Eligibility

Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286779

  Show 42 Study Locations
Sponsors and Collaborators
Baxalta US Inc.
Investigators
Study Director: Lydia Abad Franch, MD Shire
  More Information

Responsible Party: Baxalta US Inc.
ClinicalTrials.gov Identifier: NCT01286779     History of Changes
Other Study ID Numbers: 251001
2010-022726-33 ( EudraCT Number )
Study First Received: January 26, 2011
Last Updated: June 6, 2017

Additional relevant MeSH terms:
Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked

ClinicalTrials.gov processed this record on July 28, 2017