NCT01522170终止不适用
An Observational, Multi-Center, Multi-National, Long Term Follow-Up Study of Atypical Hemolytic Uremic Syndrome (aHUS) Patients Treated With Eculizumab in a Prior Clinical Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 94
- 试验地点
- 55
- 主要终点
- TMA complication-free survival
研究概览
简要总结
There is growing but limited information on the long term clinical status of aHUS patients who have previously received or are continuing to receive treatment with eculizumab. This study is designed to collect clinical data that will provide insight into the long-term outcomes of patients with aHUS.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aHUS patients who participated in any one of the aHUS-eculizumab clinical studies.
- •aHUS patients or legal representative who are able and willing to given written informed consent for their study information to be collected and retained in a database.
排除标准
- •Not applicable.
结局指标
主要结局
TMA complication-free survival
时间窗: 5 Years
Assess the long term efficacy of eculizumab in patients with aHUS who have previously participated in an eculizumab clinical study.
次要结局
- Duration of response, change over time of value for platelets, LDH, eGFR, Hgb, TMA intervention(5 Years)
研究者
研究点 (55)
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