NCT01361126

A Safety and Efficacy Study of a Recombinant Factor IX in Patients With Severe Hemophilia B

A Phase I/II Open-label, Multicenter, Safety and Efficacy Study of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) in Subjects With Hemophilia B

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: CSL Behring · Industry
• Sex: Male
• Age: 12 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study will examine the safety and efficacy of a Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) for the control and prevention of bleeding episodes in subjects who have previously received factor replacement therapy for hemophilia B. The study consists of a screening period, a pharmacokinetic (PK) period, followed by approximately a 5 month treatment period. Subjects will receive weekly routine prophylactic therapy and on-demand treatment for bleeding episodes. In addition, subjects who are not on routine factor replacement therapy prior to the study will receive only on-demand treatment for bleeding episodes.

Conditions

• Hemophilia B

Interventions

Type	Name	Description
BIOLOGICAL	Recombinant Coagulation Factor IX Albumin Fusion Protein	Study subjects will receive a single dose of 25IU/kg of rIX\_FP for pharmacokinetic analysis. Subjects will then be treated for approximately 5 months. The treatment dose will be based on the subject's PK profile and the subject's bleeding phenotype.

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-06-01
• Completion: 2012-07-01
• First posted: 2011-05-26
• Last updated: 2016-05-09
• Results posted: 2016-05-09

Locations

2 sites across 2 countries: Bulgaria, Israel