NCT01410916已完成2 期
An Open-Label, Multi-Center Trial of Eculizumab in Patients With Shiga-Toxin Producing Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 22
- 主要终点
- Improvement in Systemic TMA & Vital Organ Involvement at 8 weeks of treatment defined as either complete or partial responder based on hematologic normalization/improvement & clinically important improvement in Vital Organs: Brain, Kidney, and Thrombosis
研究概览
简要总结
This protocol is designed to collect safety and efficacy data on patients that have been or will be treated with eculizumab for STEC-HUS, in the context of the 2011 STEC-HUS epidemic in Germany.
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
- 2 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be willing and able to give written informed consent/Assent.
- •Adults, adolescents, or pediatric (≥2 months and ≥5kg) patients
- •Patient has been diagnosed with Escherichia Coli Hemolytic-Uremic Syndrome (STEC-HUS)
排除标准
- •Known complement regulatory mutation or family history of complement regulatory mutation
- •Unresolved systemic meningococcal disease
- •3. Hypersensitivity to eculizumab, to murine proteins or to one of the excipients
结局指标
主要结局
Improvement in Systemic TMA & Vital Organ Involvement at 8 weeks of treatment defined as either complete or partial responder based on hematologic normalization/improvement & clinically important improvement in Vital Organs: Brain, Kidney, and Thrombosis
时间窗: 8 weeks
Analysis of primary endpoint will occur after all patients have reached 8 weeks of treatment. The response rate will be summarized as patients who are either a complete or partial responder.
次要结局
未报告次要终点
研究者
研究点 (22)
Loading locations...
相似试验
已完成
2 期
Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-sensitive Atypical Hemolytic Uremic Syndrome (aHUS)Atypical Hemolytic Uremic SyndromeNCT00838513Alexion Pharmaceuticals, Inc.15
已完成
2 期
Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Resistant aHUSAtypical Hemolytic Uremic SyndromeNCT00844844Alexion Pharmaceuticals, Inc.1
已完成
2 期
Open Label Controlled Trial of Eculizumab in Adolescent Patients With Plasma Therapy-Sensitive aHUSAtypical Hemolytic Uremic SyndromeNCT00844428Alexion Pharmaceuticals, Inc.5
已完成
2 期
Open Label Controlled Trial of Eculizumab in Adult Patients With Plasma Therapy-Resistant aHUSAtypical Hemolytic Uremic SyndromeNCT00844545Alexion Pharmaceuticals, Inc.16
已完成
3 期
A Study to Evaluate Raptiva in Adults With Plaque Psoriasis Previously Enrolled in Study ACD2390gPsoriasisNCT00109252Genentech, Inc.