Detail of the clinical trial

Title of the trial IMMUNINE - Purified Factor IX Concentrate Virus-Inactivated: A Phase IV, Prospective, Open-label Multicenter Study to Prospectively Document the Exposure of IMMUNINE and to Monitor FIX Inhibitors in Previously Treated Patients with Severe (FIX level 1%) or Moderately Severe (FIX level <_2%) Hemophilia B Who are Planned to Enter BAX 326 Study 250901 to investigate a New Recombinant FIX Concentrate
EudraCT number 2009-016719-39
Protocol number 050901_
Sponsor Baxter Innovations GmbH, Vienna, Rakousko
Indications Hematology
Diagnosis hemophilia
Population in clinical trial Adolescents (12-17 years)
Adults (18-65 years)
Year of receiving the request to Institute (SÚKL) 2010
Date of approval by Institute (SÚKL) 19.3.2010
Date of approval by EC 7.4.2010
Date of initiation CT in ČR 2.9.2010
Date of ending CT in ČR 18.4.2011
Sites UK 2 LF a FN Motol, Klinika dětské hematologie a onkologie, Praha 5
Oddělení klinické hematologie, FN Brno (discontinued)

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