NCT00244114已完成不适用
In Vitro Evaluation Of Allergic Reactions In Hemophilia B Subjects Who Have Exhibited A Systemic Allergic Response After Exposure To BeneFIX (Nonacog Alfa; Recombinant Factor IX)
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 20 人开始时间: 2006年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 主要终点
- Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study Group:
- •Written informed consent or assent, as applicable.
- •Subjects with moderate to severe Hemophilia B (FIX:C <5%), who have reported class II or class III allergic manifestations within 24 hours of a BeneFIX infusion.
- •Control Group:
- •Written informed consent or assent, as applicable.
- •Subjects with moderate to severe Hemophilia B (FIX:C <5%)
排除标准
- •Study group:
- •Subjects who had no reaction when rechallenged with BeneFIX, in the absence of prophylactic immunomodulating therapy.
- •Subjects whose most recent allergic manifestations with BeneFIX occurred >36 months prior to providing written informed consent for this study.
- •Subjects who have taken antihistamine, steroidal, or other immunosuppressive therapy within 72 hours of the scheduled visit for this study.
- •Subjects with immune disorders.
- •Subjects unable to comply with a minimum 5-day FIX washout requirement.
- •Control group:
- •Subjects with documented evidence of prior allergic reaction to any FIX product.
- •Subjects with documented evidence of prior or current FIX inhibitor (BU >0.6).
- •Subjects have taken antihistamine, steroidal, or other immunosuppressive therapy within 72 hours of the scheduled study blood draw.
- •Subjects with immune disorder.
- •Subjects unable to comply with a minimum 5-day FIX washout requirement.
研究组 & 干预措施
A
干预措施: Blood draw (Procedure)
B
干预措施: Blood draw (Procedure)
结局指标
主要结局
Descriptive presentation of the results of the Basophil histamine release assay for both study and control groups
时间窗: within 36 months after allergic reaction
次要结局
- Collect and evaluate adverse events that occur from the time the subject signs the informed consent form to 15 days following the study visit will be collected(15 days)
- Any serious adverse events and/or adverse events of special interest occurring outside of the predefined study reporting period noted to be possibly, probably or definitely related to treatment with BeneFIX will be reported.(15 days following study blood draw)
研究者
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