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) Male Female Patients |
| 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 |
| Notice | |
| Sites |
UK 2 LF a FN Motol, Klinika dětské hematologie a onkologie, Praha 5 Oddělení klinické hematologie, FN Brno (discontinued) |
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