- * Male subjects, 12 to 65 years old
- * Severe hemophilia B (FIX activity of ≤ 2%)
- * Subjects who have received FIX products (plasma-derived and/or recombinant FIX) for \> 150 exposure days (EDs)
- * 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
- * On-demand subjects only, who have experienced a minimum average of 2 non-trauma induced bleeding episodes requiring treatment with a FIX product during the previous 6 or 3 months
Hemophilia B
A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
NCT01496274 | PHASE 2 | INTERVENTIONAL
This study will examine the safety, pharmacokinetics and efficacy of rIX-FP for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B.
Trial Information
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Rush University Medical Center
Chicago,Illinois,United States,60612
Indiana Hemophilia and Thrombosis Center, Inc.
Indianapolis,Indiana,United States,46260
Hospital of the University of Pennsylvania
Philadelphia,Pennsylvania,United States,19104
BloodCenter of Wisconsin
Milwaukee,Wisconsin,United States,53201
AKH Wien Hmatologie, Hmostaseol
Wien,Austria
SHAT "Joan Pavel" OOD Hemorrhagic Diathesis and Anemia
Sophia,Bulgaria,1233
Centre Hospitalier Universitaire de BrestCHU Morvan
Brest,France,29609
C.R.T.H. Hp. BictreHmophilie
Le Kremlin-Bicêtre,France,94275
CHU de Lyon Hpital Edouard Herriot Hemophilie
Lyon,France,0369437
Hpital NeckerCRTH
Paris,France,75015
Instit. fr Experimentelle Hmato & Transfusionsmedizin
Bonn,Germany
Zentralkrankenhaus Prof. HessKinderklinik
Bremen,Germany,28205
Unikinderklinik FrankfurtMain Kinderheilkunde
Frankfurt,Germany
Universittsklinikum HamburgEppendorf, Abt fr Pdiatr. Hmatologie
Hamburg,Germany,20246
WerlhofInst. Hannover
Hannover,Germany
Chaim Sheba Medical Center
Tel Aviv,Israel
IRCCS Ospedale MaggioreCentro emofilia e Trombosi
Milano,Italy
A.O.U. di Parma Centro di Rif. Reg. per la cura dell'Emofil
Parma,Italy,43126
Osp. S.Bortolo ULSS N. Terapie Cell. ed Ematologia
Vicenza,Italy,36100
Nara Medical University Hospital PEDIATRICS
Kashihara,Japan,634-8522
University of Occupational and Environmental Health
Kitakyushu,Japan
Nagoya University Hospital
Nagoya,Japan,466-8550
The Hospital of Hyogo College of Medicine
Nishinomiya,Japan
Ogikubo Hospital
Tokyo,Japan,167-0035
Tokyo Medical University Hospital
Tokyo,Japan
St. Marianna University, School of Medicine, Yokohama Seibu
Yokohama,Japan,241-0811
FGU "Kirov Research Institute of Haemotology and Blood Trans
Kirov,Russian Federation,610027
C.H.U. A Corua Hematologa
A Coruna,Spain
H.U.Vall d'Hebrn Hemofillia
Barcelona,Spain
H.U. La Paz Coagulopatias Congnitas
Madrid,Spain,28046
Study Eligibility Criteria
Additional Studies
Additional studies can be found at ClinicalTrials.gov