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BAX 326 (rFIX) Continuation Study

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ClinicalTrials.gov Identifier: NCT01286779
Recruitment Status : Completed
First Posted : January 31, 2011
Last Update Posted : October 23, 2017
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

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.

Condition or disease Intervention/treatment Phase
Hemophilia B Biological: BAX 326 (Recombinant factor IX) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : April 12, 2011
Primary Completion Date : June 29, 2017
Study Completion Date : June 29, 2017

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01286779

  Hide Study Locations
Instituto de Hematología y Medicina Clíncia Rubén Dávoli
Rosario, Argentina, 2000
UNIFESP - Universidade Estadual de Sao Paulo
Sao Paulo, Brazil, 040024-002
Specialized Haematological Hospital "Joan Pavel"
Sofia, Bulgaria, 1233
Hospital Dr. Sotero del Rio
Santiago, Chile
Hospital de San Jose
Bogotá, Colombia
Centro Medico Imbanaco
Cali, Colombia
Hospital Pablo Tobon Uribe
Medellin, Colombia, 005543
Klinika detské hematologie a onkologie
Prague, Czechia, 150 06
Maulana Azad Medical College and Associated Hospital
New Delhi, India, 110002
St. James's Hospital, National Center for Hereditary Coagulation Disorders
Dublin, Ireland, 8
University Hospital Policlinico Vittorio Emanuele, Hospital Ferrarotto Alessi
Catania, Italy, 95124
University Hospital Careggi, Agency of Hemophilia - Regional Reference Center for Inherited Bleeding
Florence, Italy, 50134
University of Foggia Riuniti Hospital, Department of Clinical and Experimental Medicine
Foggia, Italy, 71100
Hospital San Giovanni Bosco, Center for Hemophilia and Thrombosis, Department of Hematology
Naples, Italy, 80144
Padova University Hospital, Medical Clinic II, Center for Hemophilia
Padova, Italy, 35128
Nara Medical University, Department of Pediatrics
Nara, Japan, 634-8251
Tokyo Medical University
Tokyo, Japan, 160-0023
Ogikubo Hospital
Tokyo, Japan, 167-0035
Hematology and Transplantology Clinic, University Clinic Centre - Medical University Hospital
Gdansk, Poland, 80-952
University Pediatric Hospital in Cracow
Krakow, Poland, 30-663
Medical College of the Jagiellonian University, Department of Hematology
Krakow, Poland, 31-501
Copernicus Hospital, Medical University in Lodz, Department of Hematology
Lodz, Poland, 93-510
Professor Tadeusz Sokolowski Independent Public Teaching Hospital No. 1 of the Pomeranian Medical University in Szczecin
Szczecin, Poland, 71-252
Klinika Hematologii
Warsaw, Poland, 00-579
Institute of Haematology and Transfusion Medicine
Warsaw, Poland, 02-776
Prof. Dr. C.T. Nicolau National Institute for Transfusional Hematology
Bucharest, Romania, 11156
Louis Turcanu Emergency Clinical Children´s Hospital
Timisoara, Romania
Russian Federation
Regional clinical hospital
Ekaterinburg, Russian Federation, 620149
Federal State Institution Kirov Hematology and Blood Transfusion Research Institute under the Federal Agency for High-Tech Medical Care
Kirov, Russian Federation, 610027
Pediatric Regional Clinical Hospital, Hematology Department
Krasnodar, Russian Federation, 350007
Hematology Research Center RAMS, Department of Reconstructive Orthopedics for Haemophilia Patients
Moscow, Russian Federation, 125167
Republican Center for Hemophilia Treatment Outpatient Clinic No. 37
St. Petersburg, Russian Federation, 195213
Malmö University Hospital, Department of Coagulation Disorders
Malmö, Sweden, 205 02
Taipei Medical University Hospital
Taipei City, Taipei, Taiwan, 110
Chung-Ho Memorial Hospital
Kaohsiung, Taiwan, 807
China Medical University Hospital
Taichung, Taiwan, 40447
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
National Taiwan University Hospital
Taipei, Taiwan, 10002
Tri-Service General Hospital
Taipei, Taiwan, 114
State Institution "Institute of Blood Pathology and Transfusion Medicine of the Academy of Medical Sciences of Ukraine"
Lviv, Ukraine, 79044
United Kingdom
Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital
London, United Kingdom, NW3 2QG
Manchester Children's Hospital
Manchester, United Kingdom, M13 9WL
Sponsors and Collaborators
Baxalta now part of Shire
Study Director: Lydia Abad Franch, MD Shire

Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT01286779     History of Changes
Other Study ID Numbers: 251001
2010-022726-33 ( EudraCT Number )
First Posted: January 31, 2011    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: September 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