NCT01233440 - Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

July 31, 2011

Study Completion Date

July 31, 2011

Conditions

Hemophilia B

Interventions

BIOLOGICAL

Recombinant Coagulation Factor IX Albumin Fusion Protein

Single dose of 25, 50 or 75 IU/kg of rIX-FP, given as intravenous infusion

BIOLOGICAL

Plasma derived FIX [pdFIX]

Single dose of 50 IU/kg of reference product, given as intravenous infusion

Trial Locations (20)

Study site, Vienna

Study site, Le Kremlin-Bicêtre

Study Site, Lyon

Study site, Nantes

Study site, Paris

Study Site, Berlin

Study Site, Hamburg

Study Site, Hanover

Study site, Münster

Study Site, Tel Litwinsky

Study Site, Catania

Study Site, Florence

Study Site, Genova

Study site, Milan

Study Site, Napoli

Study Site, Parma

Study Site, Vicenza

Study Site, A Coruña

Study Site, Barcelona

Study Site, Madrid