NCT00151385撤回4 期
A Multicenter Study to Describe the Immunogenic Epitope(s) of Factor VIII in Previously Treated Patients With Congenital Hemophilia A Who Develop De Novo Factor VIII Inhibitors While Receiving Factor VIII Infusion Therapy.
Wyeth is now a wholly owned subsidiary of Pfizer23 个研究点 分布在 7 个国家开始时间: 2005年11月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 23
- 主要终点
- Description of the patterns of antibodies and associated epitopes in a subset of
研究概览
简要总结
This investigation will utilize a systematic determination of anti-FVIII antibody specificity in PTPs (> 50 ED) with hemophilia A who have developed inhibitors in response to treatment with any FVIII product(s). A group of patients with hemophilia A, who have no evidence of current or prior FVIII inhibitor will be included for comparison. The objective of this study is to describe the patterns of antibodies and associated epitopes in the study population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •· Patients with moderate or severe congenital hemophilia A, a current FVIII inhibitor, who have taken at least two different FVIII products during their lifetime.
排除标准
- •Patients who have had an inhibitor prior to their current inhibitor.
- •Patients with immune disorders.
结局指标
主要结局
Description of the patterns of antibodies and associated epitopes in a subset of
previously treated patients with hemophilia A.
次要结局
未报告次要终点
研究者
研究点 (23)
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