A Phase 3 interventional study of BeneFIX in Hemophilia B, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed at 6 sites in United States. Open to participants aged Up to 5 Years. Per ClinicalTrials.gov, last updated 2007-12-27.
Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 3, Interventional, and Treatment
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.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's enrollment of 20 is below the median of 28 across 512 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.
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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.
To measure the incremental recovery of rFIX in children following a 75-IU/kg bolus infusion.
This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.
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Wyeth is now a wholly owned subsidiary of Pfizer