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

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.

Timeline

Start

2011-07

Primary completion

2012-06

Completion

2012-07

Outcome

Met primary endpoint

release “This trial showed that less frequent infusions were needed with CSL Behring’s investigational rIX-FP compared to currently available FIX products” csl.com ↗

Drugs

Indications