A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B

Completed · Phase 2/Phase 3

Conditions studied: Hemophilia B

In brief

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.

Key facts

Study ID

NCT01496274

Run by

CSL Behring

People needed

63

Starts

2012-02-01

Last updated by the study team

2016-05-09

Who can join

Age: 12 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known hypersensitivity to any FIX product or hamster protein
• Known congenital or acquired coagulation disorder other than congenital FIX deficiency
• HIV positive subjects with a CD4 count < 200/mm3
• Low platelet count, kidney or liver dysfunction
• Recent life-threatening bleeding episode

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States
• Indiana Hemophilia and Thrombosis Center, Inc. — Indianapolis, Indiana, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• BloodCenter of Wisconsin — Milwaukee, Wisconsin, United States
• AKH Wien [Hämatologie, Hämostaseol — Vienna, Austria
• SHAT "Joan Pavel" OOD [Hemorrhagic Diathesis and Anemia] — Sofia, Bulgaria
• Centre Hospitalier Universitaire de Brest/CHU Morvan — Brest, France
• C.R.T.H. Hôp. Bicêtre-Hémophilie — Le Kremlin-Bicêtre, France
• CHU de Lyon - Hôpital Edouard Herriot [Hemophilie] — Lyon, France
• Hôpital Necker-CRTH — Paris, France
• Instit. für Experimentelle - Hämato & Transfusionsmedizin — Bonn, Germany
• Zentralkrankenhaus Prof. Hess-Kinderklinik — Bremen, Germany
• Unikinderklinik Frankfurt/Main [Kinderheilkunde] — Frankfurt, Germany
• Universitätsklinikum Hamburg-Eppendorf, Abt für Pädiatr. Hämatologie — Hamburg, Germany
• Werlhof-Inst. Hannover — Hanover, Germany
• Chaim Sheba Medical Center — Tel Aviv, Israel
• IRCCS Ospedale Maggiore[Centro emofilia e Trombosi] — Milan, Italy
• A.O.U. di Parma [Centro di Rif. Reg. per la cura dell'Emofil — Parma, Italy
• Osp. S.Bortolo ULSS N.6 [Terapie Cell. ed Ematologia] — Vicenza, Italy
• Nara Medical University Hospital [PEDIATRICS] — Kashihara, Japan
• University of Occupational and Environmental Health — Kitakyushu, Japan
• Nagoya University Hospital — Nagoya, Japan
• The Hospital of Hyogo College of Medicine — Nishinomiya, Japan
• Ogikubo Hospital — Tokyo, Japan
• Tokyo Medical University Hospital — Tokyo, Japan

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.