EVALUATION OF POTENTIAL PREDICTORS OF DISEASE PROGRESSION IN PATIENTS WITH aHUS, INCLUDING GENETICS, BIOMARKERS, AND TREATMENT - EVIDENCE

Alexion Pharmaceuticals, Inc.0 个研究点目标入组 330 人开始时间: 2016年6月1日最近更新: 2017年11月6日

适应症

试验速览

暂无简介。

•1. Currently receiving eculizumab treatment in the M11-001 aHUS Registry
•2. Two normal platelet counts at least 4 week apart
•3. Two normal LDH levels at least 4 weeks apart
•4. Willing, committed, and able to return for all clinic visits and complete all study related procedures
•5. Patient or patient's parent/legal guardian must be willing and able to give written informed consent. Patient (if minor) must be willing to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committee [IRB/IEC])
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 125
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 155
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•1. Any prior intentional discontinuation of eculizumab treatment
•2. On chronic dialysis (defined as =3 months on dialysis)
•3. Currently participating in another complement inhibitor trial
•4. With life expectancy of <6 months
•5. Patient or patient's parent/legal guardian unable to give written informed consent. Patient (if minor) unable to give written informed assent (if applicable as determined by the central Institutional Review Boards/Independent Ethics Committee [IRB/IEC]).

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