Covalent Tolerance Induction to Factor VIII-Prediction of Inhibitors in Hemophilia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Inactivation of antibodies by the FVIII covalent reactive analogs
研究概览
简要总结
To correlate the Human Leukocyte Antigen type and genetic defect with hemophilia A.
详细描述
One of the most serious complications of treatment in patients with hemophilia A or hemophilia B is the development of an inhibitor, which is an antibody that neutralizes the factor VIII or IX coagulant activity. Up to one fourth of patients with severe hemophilia A develop an inhibitor but at present it is not possible to predict which patients will develop such antibody. The ability to predict an inhibitor development at an individual level would greatly improve therapeutic approach to this serious problem
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 99 Years（Child, Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Severe Hemophilia A with an inhibitor level of 0.6 B.U. or higher
排除标准
- •Severe Hemophilia A with a negative inhibitor
结局指标
主要结局
Inactivation of antibodies by the FVIII covalent reactive analogs
时间窗: 6 months
次要结局
未报告次要终点
研究者
Miguel Escobar
Associate Professor - Gulf States Hemophilia Center
The University of Texas Health Science Center, Houston