A Retrospective, Observational, Non-interventional Trial to Assess Eculizumab Treatment Effect in Patients With Atypical Hemolytic Uremic Syndrome (aHUS)

Alexion Pharmaceuticals, Inc.0 个研究点目标入组 30 人开始时间: 2009年8月31日最近更新: 2023年8月18日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Alexion Pharmaceuticals, Inc.
入组人数: 30
主要终点: Overall safety and tolerability of eculizumab based on Adverse Events of Special Interest/Adverse Drug Reactions and Additional Adverse Events.

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The objective of this retrospective trial is to assess safety and efficacy of eculizumab in aHUS patients treated outside of an Alexion-sponsored controlled clinical trial.

研究设计

研究类型: Observational
观察模型: Other
时间视角: Retrospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Male or female patients of any age who have been diagnosed with aHUS.
•Received at least one dose of eculizumab for the treatment of aHUS between 2007 and 2009 outside of an Alexion sponsored controlled clinical trial.

排除标准

•Patients who have participated or are currently participating in a controlled clinical trial of eculizumab

结局指标

主要结局

Overall safety and tolerability of eculizumab based on Adverse Events of Special Interest/Adverse Drug Reactions and Additional Adverse Events.

时间窗: Through 26 weeks

次要结局

Assess eculizumab treatment affect based on change in laboratory parameters (platelets, hemoglobin, LDH and parameters associated with renal function and intravascular hemolysis) and reduction of thrombotic microangiopathy (TMA).(Through 26 weeks)

研究者

发起方

Alexion Pharmaceuticals, Inc.

申办方类型

Industry

责任方

Sponsor

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