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Last Updated: August 14, 2020

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CLINICAL TRIALS PROFILE FOR BENEFIX

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All Clinical Trials for BENEFIX

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00037557 Study Evaluating rFIX; BeneFIX in Severe Hemophilia B Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 3 2002-09-01 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.
NCT00093171 Study Evaluating rFIX; BeneFIX® in Hemophilia B Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 3 1969-12-31 The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).
NCT00093210 Study Evaluating of Recombinant Human Factor IX (BeneFIX) and a New Formulation of BeneFIX (rFIX-R) in Moderate to Severe Hemophilia B Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 3 1969-12-31 The primary objective of this clinical research study is to establish the bioequivalence of 2 treatments, rFIX and rFIX-R, when given as a 10-minute intravenous bolus infusion.
NCT00244114 Study Evaluating Allergic Reactions To Benefix In Hemophilia B Patients Completed Wyeth is now a wholly owned subsidiary of Pfizer Phase 4 2006-02-01 Based on the finding that anaphylactic reactions to Benefix ("FIX") are associated with a specific IgE, a Basophil histamine release assay was selected to evaluate and demonstrate subject sensitization to FIX.
NCT00364182 Study Comparing On-Demand Treatment With Two Prophylaxis Regimens Of BeneFIX In Patients With Severe Hemophilia B Completed Pfizer Phase 3 2007-05-01 This study is designed to evaluate BeneFIX infused as prophylaxis regimens, compared with BeneFIX administered as an on-demand regimen only. In the trial, subjects will participate in 4 study periods. The first period is a 16-week on-demand treatment, during which subjects will utilize BeneFIX to treat bleeding events episodically only as they occur (i.e., on-demand treatment). At the end of this period, subjects will be randomly assigned to 1 of 2 BeneFIX prophylaxis regimens: either 100 IU/kg once weekly or 50 IU/kg twice weekly, and followed for 16 weeks. At the end of this period, subjects will use on-demand treatment for 8 weeks. The purpose of this 8-week period is to mitigate the potential carry-over effect of the prior prophylaxis regimen on bleeding frequency. Following this 8-week on-demand treatment, subjects will cross-over and receive the alternate study prophylactic regimen for 16 weeks. The primary endpoint is annualized number of bleeding episodes, compared between the first on-demand period and each of the prophylaxis regimens. A comparison of annualized bleeding episodes between the two prophylaxis regimens will also be performed. Subject-reported outcomes will also be collected using a patient diary. At 24 and 48 hours following the onset of each joint bleeding episode, information on pain, sleep, and work will be collected. Additional data on physical functioning will be recorded on the diary at the end of the 16-week on-demand period, and at the end of each prophylaxis period. Information on safety will also be collected. Each subject will participate in this study for approximately 59 weeks (15 months), including a screening period of up to 3 weeks, an initial 16-week on-demand period, two prophylaxis treatment periods of 16 weeks each, separated by an 8-week on-demand treatment period. A modified FIX recovery study will be performed once during each prophylaxis period. The study diary will also be used by subjects to collect secondary endpoints. These endpoints, which are subject-reported outcomes, will be recorded in the diary at 24 and 48 hours following the onset of each joint bleeding episode. Additional data on physical functioning will be recorded on the diary at the end of the 16-week on-demand period, and at the end of each prophylaxis period. Patients will be recruited in the United States, Canada, Europe and Russia.
NCT00484185 Post Marketing Surveillance To Observe Safety and Efficacy Of BeneFIX In Patients With Hemophilia B Completed Pfizer N/A 2007-08-01 To provide safety and effectiveness information of BeneFIX during the post-marketing period as required by Korea FDA regulations, to identify any potential drug related treatment factors in Korean population including: 1) Unknown adverse reactions, especially serious adverse reactions; 2) Changes in the incidences of adverse reactions under the routine drug uses. 3) Factors that may affect the safety of the drug 4) Factors that may affect the effectiveness of the drug
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for BENEFIX

Condition Name

Condition Name for BENEFIX
Intervention Trials
Hemophilia B 11
Severe Hemophilia B 1
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Condition MeSH

Condition MeSH for BENEFIX
Intervention Trials
Hemophilia B 12
Hemophilia A 10
Hypersensitivity 1
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Clinical Trial Locations for BENEFIX

Trials by Country

Trials by Country for BENEFIX
Location Trials
United States 25
China 16
Canada 6
Germany 5
India 3
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Trials by US State

Trials by US State for BENEFIX
Location Trials
Texas 3
New Jersey 3
Michigan 3
Colorado 3
Illinois 2
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Clinical Trial Progress for BENEFIX

Clinical Trial Phase

Clinical Trial Phase for BENEFIX
Clinical Trial Phase Trials
Phase 4 3
Phase 3 5
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for BENEFIX
Clinical Trial Phase Trials
Completed 11
Recruiting 1
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Clinical Trial Sponsors for BENEFIX

Sponsor Name

Sponsor Name for BENEFIX
Sponsor Trials
Pfizer 6
Wyeth is now a wholly owned subsidiary of Pfizer 5
Biogen 1
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Sponsor Type

Sponsor Type for BENEFIX
Sponsor Trials
Industry 13
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Serving leading biopharmaceutical companies globally:

McKinsey
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