Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
23 participants
INTERVENTIONAL
2011-12-20
2013-05-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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BAX326 < 6 years of age
BAX326
All participants underwent a pharmacokinetic evaluation with BAX326 (recombinant Factor IX) followed by twice weekly prophylactic treatment for 6 months or for at least 50 exposure days, whichever occurred last.
BAX326 6 to <12 years of age
BAX326
All participants underwent a pharmacokinetic evaluation with BAX326 (recombinant Factor IX) followed by twice weekly prophylactic treatment for 6 months or for at least 50 exposure days, whichever occurred last.
Interventions
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BAX326
All participants underwent a pharmacokinetic evaluation with BAX326 (recombinant Factor IX) followed by twice weekly prophylactic treatment for 6 months or for at least 50 exposure days, whichever occurred last.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participant has severe (FIX level \< 1%) or moderately severe (FIX level ≤ 2%) hemophilia B
* Participant is \< 12 years old at the time of screening
* Participant has no evidence of a history of FIX inhibitors (based on the participant's medical records)
* Participant is immunocompetent as evidenced by a CD4 count ≥ 200 cells/mm\^3
Exclusion Criteria
* Participant has a history of allergic reaction, e.g. anaphylaxis, following exposure to FIX concentrate(s)
* Participant has evidence of an ongoing or recent thrombotic disease
* Participant has an inherited or acquired hemostatic defect other than hemophilia B
12 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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LNJP Maulana Azad Medical College & Associated Hospitals
New Delhi, , India
University Pediatric Hospital
Krakow, , Poland
Stanislaw Popowski Provincial Specialist Pediatric Hospital
Olsztyn, , Poland
Professor Tadeusz Sokolowski Independent Public Teaching Hospital of the Pomeranian Medical University in Szczecin
Szczecin, , Poland
S.C. Sanador SRL
Bucharest, , Romania
Louis Turcanu Emergency Children's Hospital
Timișoara, , Romania
Pediatric Regional Clinical Hospital, Hematology Department
Krasnodar, , Russia
Republican Center for Hemophilia Treatment
Saint Petersburg, , Russia
Regional Clinical Hospital
Yekaterinburg, , Russia
State Institution "Institute of Blood Pathology and Transfusion Medicine of the Academy of Medical Sciences of Ukraine"
Lviv, , Ukraine
Manchester Children´s Hospital
Manchester, , United Kingdom
Countries
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References
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Urasinski T, Stasyshyn O, Andreeva T, Rusen L, Perina FG, Oh MS, Chapman M, Pavlova BG, Valenta-Singer B, Abbuehl BE. Recombinant factor IX (BAX326) in previously treated paediatric patients with haemophilia B: a prospective clinical trial. Haemophilia. 2015 Mar;21(2):196-203. doi: 10.1111/hae.12548. Epub 2014 Dec 11.
Other Identifiers
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2011-002437-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
251101
Identifier Type: -
Identifier Source: org_study_id
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