NCT01233440

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

An Open-label, Multicenter, Dose-Escalation Safety and Pharmacokinetic Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: CSL Behring · Industry
• Sex: Male
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is comprised of both a rIX-FP dose-escalation safety segment (25, 50 and 75 IU/kg of rIX-FP), and PK evaluation of rIX-FP after a single dose of 50 IU/kg, as well as PK evaluation after a single dose of 50 IU/kg of the previously given Factor IX (FIX) product (recombinant FIX \[rFIX\] or plasma derived FIX \[pdFIX\]) which is used as the reference product.

Conditions

• Hemophilia B

Interventions

Type	Name	Description
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

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2010-11-03
• Last updated: 2012-01-31

Locations

20 sites across 6 countries: Austria, France, Germany, Israel, Italy, Spain