NCT01412047已完成不适用
A Post Marketing, Multi-Center, Trial to Measure Human Anti-Human Antibodies (HAHA) to Soliris (Eculizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 7
- 主要终点
- To summarize the proportion of patients with neutralizing HAHA antibodies.
研究概览
简要总结
How does long term treatment with Soliris affect HAHA in PNH patients?
详细描述
To determine the long term effect of Soliris (eculizumab) treatment on the presence of human anti-human antibodies (HAHA) in Paroxysmal Nocturnal Hemoglobinuria (PNH) patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PNH patients who previously participated in study E05-001;
- •Patients who have an eculizumab naive serum sample for comparison;
- •Patients who currently used commerical Soliris;
- •Patients who are willing and able to gie written informed consent.
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
To summarize the proportion of patients with neutralizing HAHA antibodies.
时间窗: Six (6) months
次要结局
- To summarize the proportion of patients with non-neutralizing HAHA antibodies.(Six (6) months)
- To summarize the proportion of patients with increased hemolysis in setting of neutralizing HAHA antibodies.(Six (6) months)
研究者
研究点 (7)
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