30
Participants
Start Date
December 19, 2011
Primary Completion Date
May 15, 2014
Study Completion Date
May 15, 2014
Recombinant factor IX
Following a loading dose with BAX326, participants will receive BAX326 as a bolus infusion. The treatment regimen will be determined by the intensity and duration of the hemostatic challenge and the institution´s standard of care. The dose will be tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries.
"Specialized Haematological Hospital Joan Pavel", Sofia
Instituto de Hematología y Medicina Clínica Rubén Dávoli, Rosario
"State Institution Institute of Blood Pathology and Transfusion Medicine under the Academy of Medical Sciences of Ukraine", Lviv
Hematology Research Center RAMS, Moscow
Children's Territorial Clinical Hospital, Krasnodar
Federal State Institution Kirov, Hematology and Blood Transfusion Research Institute under the Federal Agency for High-Tech Medical Care, Kirov
Hospital Dr. Sotero del Rio, Santiago
Centro Medico Imbanaco, Santiago de Cali
Louis Turcanu Emergency Clinical Children´s Hospital, Timișoara
Klinika detska hematologie a onkologie, Fakultni Nemocnice Motol, Prague
Medical University Lodz, Copernicus Hospital, Department of Hematology, Lodz
Independent Public Pediatric Teaching Hospital, Clinical Department of Hematology and Pediatrics, Warsaw
Institute of Haematology and Transfusion Medicine, Warsaw
Royal Manchester Children's Hospital, Department of Hematology, Manchester
Baxalta now part of Shire
INDUSTRY