- * Male subjects, younger than 12 years old.
- * Severe hemophilia B (Factor IX \[FIX\] activity of ≤ 2%).
- * Body weight ≥ 10 kg.
- * Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for \> 150 exposure days (EDs) (6 to \< 12 years), and \> 50 EDs (\< 6 years).
- * No history of FIX inhibitor formation, no detectable inhibitors at Screening and no family history of inhibitors against FIX.
- * Written informed consent for study participation.
Hemophilia B
A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B
NCT01662531 | PHASE 3 | INTERVENTIONAL
This study will examine the pharmacokinetics, safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children who have previously received factor replacement therapy for hemophilia B.
Trial Information
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The Royal Children's Hospital, Melbourne
Parkville,Victoria,Australia,3052
The Children's Hospital at Westmead
Westmead,Australia,2145
AKH Wien (Paediatrics)
Wien,Austria
McMaster Children's Hospital
Hamilton,Ontario,Canada,L8N3Z5
Fakultni nemocnice Brno
Brno,Czech Republic,62500
Fakultni nemocnice Ostrava
Ostrava,Czech Republic,70852
Fakultni nemocnice Motole
Praha 5,Czech Republic,15006
C.R.T.H. Hopital de Bicentre (Hemophilie)
Le Kremlin-Bicentre,France,94275
Hospital Edouard Herriot
Lyon,France,69437
Hpital d'enfants La Timone
Marseille,France,13385
CRC Coagulation Research Center GmbH
Duisburg/Altstadt,Germany,47051
Universittsklinikum Dsseldorf
Düsseldorf,Germany,40225
Sheba Medical Center
Tel Hashomer,Israel,52621
AOU Careggi
Firenze,Italy,50134
IRCCS Ospendale Maggiore (Centro emofilia e Trombosi)
Milano,Italy,20122
FGU "Kirov Research Institute of Haemotology and Blood Trans)
Kirov,Russian Federation,610027
H.U. La Paz
Madrid,Spain,28046
Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov