Clinical Trial: Study Evaluating rFIX; BeneFIX in Severe Hemophilia B
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Open-Label, Single-Arm, Safety and Efficacy Study of Recombinant Human Factor IX (rFIX; BeneFIX®) in Children Less Than 6 Years of Age
Brief Summary:
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.
Detailed Summary:
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Current Primary Outcome: 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.
Original Primary Outcome:
Current Secondary Outcome: To measure the incremental recovery of rFIX in children following a 75-IU/kg bolus infusion.
Original Secondary Outcome:
Information By: Wyeth is now a wholly owned subsidiary of Pfizer
Dates:
Date Received: May 17, 2002
Date Started: September 2002
Date Completion:
Last Updated: December 18, 2007
Last Verified: December 2007
