To characterize the safety and efficacy of rFIX in children less than 6 years of age with
severe hemophilia B in the setting of acute bleeding episodes, prophylaxis, and/or surgery.
This study will provide an opportunity for systematic observation of treatment with rFIX in
children less than 6 years of age regardless of prior FIX treatment. Younger patients exhibit
a different pharmacokinetic profile and therefore may respond differently to rFIX infusions
when compared with older children and adults. This evaluation will provide data from which
recommendations can be made regarding rFIX dosing and treatment of these patients.
Surveillance for certain observations that have been made in patients treated with rFIX in
the clinical and postmarketing setting will be performed, including inhibitor development,
thrombogenicity, FIX recovery/lack of effect, allergic-type manifestations, and RBC
agglutination. Comparisons will be derived from published reports and communications
describing experience with other FIX products and protein therapeutics in general.