EUCTR2004-002648-88-GB进行中（未招募）1 期
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) - Basophil Clinical Study
Wyeth Pharmaceuticals0 个研究点目标入组 18 人开始时间: 2005年4月19日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Study Group:
- •1. Written informed consent or assent, as applicable.
- •2. Subjects with moderate to severe hemophilia B (FIX: C <5%), who have reported class II (systemic with respiratory involvement) or class III (severe anaphylaxis with hypotension) allergic manifestations within 24 hours of a BeneFIX infusion.
- •Control Group:
- •1. Written informed consent or assent, as applicable.
- •2. Subjects with moderate to severe hemophilia B (FIX: c <5%).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Study Group:
- •1. Subjects who had NO reaction when rechallenged with BeneFIX, in the absence of prophylactic immunomodulating therapy.
- •2. Subjects whose most recent allergic manifestations with BeneFIX occurred > 36 months prior to providing written consent for this study.
- •3. Subjects who have taken antihistamine, steroidal, or other immunosuppressive therapy within 72 hours of the scheduled visit for this study.
- •4. Subjects with immune disorders (e.g. HIV, myeloma, lymphoma).
- •5. Subjects unable to comply with a minimum 5-day FIX washout requirement.
- •Control Group:
- •1. Subjects with documented evidence of prior class II or class III allergic reaction to any FIX product.
- •2. Subjects with documeted evidence of prior or current FIX inhibitor (BU > or = to 0.6).
- •3. Subjects who have taken antihistimine, steroidal, or other immunosuppresive therapy within 72 hours of the scheduled study visit.
- •4. Subjects with immune disorder (e.g. HIV, myeloma, lymphoma).
- •5. Subjects unable to comply with a minimum 5-day FIX washout requirement.
研究者
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