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: May 24, 2016
Last verified: May 2016
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
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 ] [ Designated as safety issue: Yes ]
    Descriptive analysis


Enrollment: 117
Study Start Date: April 2011
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 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
Genders Eligible for Study:   Both
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: Nirjhar Chatterjee, MD Baxalta US Inc.
  More Information

Responsible Party: Baxalta US Inc.
ClinicalTrials.gov Identifier: NCT01286779     History of Changes
Other Study ID Numbers: 251001  2010-022726-33 
Study First Received: January 26, 2011
Last Updated: May 24, 2016
Health Authority: United States: Food and Drug Administration
Chile: Instituto de Salud Pública de Chile
Czech Republic: State Institute for Drug Control
Brazil: Agencia Nacional de Vigilance Sanitaria (ANVISA)
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Ukraine: State Pharmacological Center - Ministry of Health
Japan: Pharmaceuticals and Medical Devices Agency
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Sweden: Medical Products Agency
Russia: FSI Scientific Center of Expertise of Medical Application
Romania: National Medicines Agency
Bulgaria: Bulgarian Drug Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
India: Drugs Controller General of India
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on May 26, 2016