Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B

Phase 1 Completed 25 enrolled CSL Behring

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of the study is to assess the safety of IV administration of rIX-FP. Safety will be evaluated by adverse events and laboratory changes over time. The secondary objective of the study is to evaluate the pharmacokinetics parameters, following a single intravenous dose of rIX-FP.

Timeline

Start: 2010-10
Primary completion: 2011-07
Completion: 2011-07

Publications

Santagostino E, Negrier C, Klamroth R, Tiede A, Pabinger-Fasching I, Voigt C, Jacobs I, Morfini M. Safety and pharmacokinetics of a novel recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in hemophilia B patients. Blood. 2012 Sep 20;120(12):2405-11. doi: 10.1182/blood-2012-05-429688. Epub 2012 Aug 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Plasma derived FIX	Protein / enzyme biologic	50 iu/kg	Intravenous
Subject	Recombinant Coagulation Factor IX Albumin Fusion Protein	Protein / enzyme biologic	25 iu/kg	Intravenous
Subject	Recombinant Coagulation Factor IX Albumin Fusion Protein	Protein / enzyme biologic	50 iu/kg	Intravenous
Subject	Recombinant Coagulation Factor IX Albumin Fusion Protein	Protein / enzyme biologic	75 iu/kg	Intravenous

Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein in Subjects With Hemophilia B

Summary

Timeline

Publications

Drugs

Indications