Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
117 participants
INTERVENTIONAL
2011-04-12
2017-06-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BAX 326
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.
Interventions
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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 Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
65 Years
ALL
No
Sponsors
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Baxalta now part of Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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Instituto de Hematología y Medicina Clíncia Rubén Dávoli
Rosario, , Argentina
UNIFESP - Universidade Estadual de Sao Paulo
São Paulo, , Brazil
Specialized Haematological Hospital "Joan Pavel"
Sofia, , Bulgaria
Hospital Dr. Sotero del Rio
Santiago, , Chile
Hospital de San Jose
Bogotá, , Colombia
Centro Medico Imbanaco
Cali, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Klinika detské hematologie a onkologie
Prague, , Czechia
Maulana Azad Medical College and Associated Hospital
New Delhi, , India
St. James's Hospital, National Center for Hereditary Coagulation Disorders
Dublin, , Ireland
University Hospital Policlinico Vittorio Emanuele, Hospital Ferrarotto Alessi
Catania, , Italy
University Hospital Careggi, Agency of Hemophilia - Regional Reference Center for Inherited Bleeding
Florence, , Italy
University of Foggia Riuniti Hospital, Department of Clinical and Experimental Medicine
Foggia, , Italy
Hospital San Giovanni Bosco, Center for Hemophilia and Thrombosis, Department of Hematology
Naples, , Italy
Padova University Hospital, Medical Clinic II, Center for Hemophilia
Padua, , Italy
Nara Medical University, Department of Pediatrics
Nara, , Japan
Tokyo Medical University
Tokyo, , Japan
Ogikubo Hospital
Tokyo, , Japan
Hematology and Transplantology Clinic, University Clinic Centre - Medical University Hospital
Gdansk, , Poland
University Pediatric Hospital in Cracow
Krakow, , Poland
Medical College of the Jagiellonian University, Department of Hematology
Krakow, , Poland
Copernicus Hospital, Medical University in Lodz, Department of Hematology
Lodz, , Poland
Professor Tadeusz Sokolowski Independent Public Teaching Hospital No. 1 of the Pomeranian Medical University in Szczecin
Szczecin, , Poland
Klinika Hematologii
Warsaw, , Poland
Institute of Haematology and Transfusion Medicine
Warsaw, , Poland
Prof. Dr. C.T. Nicolau National Institute for Transfusional Hematology
Bucharest, , Romania
Louis Turcanu Emergency Clinical Children´s Hospital
Timișoara, , Romania
Federal State Institution Kirov Hematology and Blood Transfusion Research Institute under the Federal Agency for High-Tech Medical Care
Kirov, , Russia
Pediatric Regional Clinical Hospital, Hematology Department
Krasnodar, , Russia
Hematology Research Center RAMS, Department of Reconstructive Orthopedics for Haemophilia Patients
Moscow, , Russia
Republican Center for Hemophilia Treatment Outpatient Clinic No. 37
Saint Petersburg, , Russia
Regional clinical hospital
Yekaterinburg, , Russia
Malmö University Hospital, Department of Coagulation Disorders
Malmo, , Sweden
Taipei Medical University Hospital
Taipei City, Taipei, Taiwan
Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
State Institution "Institute of Blood Pathology and Transfusion Medicine of the Academy of Medical Sciences of Ukraine"
Lviv, , Ukraine
Katharine Dormandy Haemophilia Centre and Haemostasis Unit, Royal Free Hospital
London, , United Kingdom
Manchester Children's Hospital
Manchester, , United Kingdom
Countries
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References
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Windyga J, Stasyshyn O, Lissitchkov T, Mamonov V, Serban M, Rusen L, Ploder B, Tangada S. Safety, Immunogenicity, and Hemostatic Efficacy of Nonacog Gamma in Patients With Severe or Moderately Severe Hemophilia B: A Continuation Study. Clin Appl Thromb Hemost. 2020 Jan-Dec;26:1076029620950836. doi: 10.1177/1076029620950836.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2010-022726-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
251001
Identifier Type: -
Identifier Source: org_study_id
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