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Clinical Trial Summary

This study will examine the long-term safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children and adults with severe hemophilia B. The study will include subjects who have not previously been treated with Factor IX products, subjects who previously completed a CSL-sponsored rIX-FP lead-in study and subjects requiring major non-emergency surgery who have not previously completed a CSL-sponsored rIX-FP lead-in study. A surgical prophylaxis substudy will examine the efficacy of rIX-FP in subjects with hemophilia B who are undergoing non-emergency major or minor surgery. An additional substudy will examine the safety and PK of subcutaneous (SC) administration of rIX-FP.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT02053792
Study type Interventional
Source CSL Behring
Contact
Status Completed
Phase Phase 3
Start date February 6, 2014
Completion date June 2, 2021

See also
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