An Open-label, Multi-center Clinical Trial of Eculizumab in Adult Patients With Atypical Hemolytic-uremic Syndrome
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 主要终点
- Percentage of Patients With Modified Complete TMA Response
研究概览
简要总结
The record Primary purpose is to assess the efficacy of eculizumab in adult patients with Atypical Hemolytic- Uremic Syndrome (aHUS) to control Thrombotic Microangiopathy (TMA) as characterized by thrombocytopenia, hemolysis and renal impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Eculizumab
干预措施: Eculizumab (Drug)
结局指标
主要结局
Percentage of Patients With Modified Complete TMA Response
时间窗: Through 26 weeks
Proportion of Patients with Modified Complete TMA response through 26 weeks of treatment was determined and defined by normalization of hematological parameters (platelet count and LDH) and improvement in renal function (defined as ≥ 25% reduction from the baseline value in serum creatinine, which were sustained for at least two consecutive measurements obtained at least four weeks apart.
Percentage of Patients With Complete TMA Response
时间窗: Through 26 weeks
Proportion of Patients with Complete TMA response was determined and defined by normalization of hematological parameters (platelet count and LDH) and preservation of renal function (defined as \< 25% increase in serum creatinine from baseline) which were sustained for at least two consecutive measurements obtained at least four weeks apart.
次要结局
- Percentage of Patients With Complete Hematologic Response(Through End of Study, Median Exposure 52 Weeks)
- Percentage of Patients With Platelet Count Normalization(Through End of Study, Median Exposure 52 Weeks)
- Percentage of Patients With Modified Complete TMA Response(Through End of Study, Median Exposure 52 Weeks)
- Platelet Count Change From Baseline to 52 Weeks(Through 52 Weeks)
- Percentage of Patients With Estimated Glomerular Filtration Rate (eGFR) Improvement(Through End of Study, Median Exposure 52 Weeks)
- Platelet Count Change From Baseline to 26 Weeks(Through 26 weeks)
- Percentage of Patients With Complete TMA Response(Through End of Study, Median Exposure 52 Weeks)