NCT05405777已完成不适用
A Retrospective Study to Evaluate the Clinical Outcome According to Treatment in Atypical Hemolytic Uremic Syndrome (aHUS) Patients in South Korea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Handok Inc.
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Clinical prognosis (Overall survival) by treatment with or without eculizumab
研究概览
简要总结
Primary objective
- To determine the clinical prognosis by identifying the disease course and severity by treatment with or without eculizumab in patients with aHUS in Korea.
Secondary objectives
- To determine the clinical prognosis of the disease in all patients with aHUS in Korea.
- To determine the clinical prognosis of the disease in patients diagnosed with aHUS prior to the initiation of eculizumab reimbursement system in Korea.
- To determine the treatment responses by treatment options in patients with aHUS in Korea.
- To identify risk factors that affect mortality in all patients with aHUS in Korea.
- To investigate the recurrence and clinical prognosis in patients with aHUS in Korea when eculizumab is discontinued
详细描述
As a retrospective, non-interventional, multi-center study
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
- •Patients who are clinically diagnosed with the aHUS
排除标准
- •Patients who are diagnosed with Shiga toxin-producing E. coli hemolytic-uremic syndrome (STEC-HUS).
- •Patients with less than 10% in a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13 (ADAMTS-13) activity test
结局指标
主要结局
Clinical prognosis (Overall survival) by treatment with or without eculizumab
时间窗: from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, whichever came first
Overall survival (OS)
Clinical prognosis (Renal survival) by treatment with or without eculizumab
时间窗: from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, or date of ESRD diagnosis, whichever came first
Renal survival (end-stage renal disease \[ESRD\]-free survival)
次要结局
- Clinical prognosis (Overall survival) of patients diagnosed with aHUS prior to the initiation of eculizumab reimbursement system in Korea(from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, whichever came first)
- Clinical prognosis (Renal survival) of patients diagnosed with aHUS prior to the initiation of eculizumab reimbursement system in Korea(from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, or date of ESRD diagnosis, whichever came first)
- Response rates of each treatment, compared to prior to start treatment(3rd and 6th months)
- Clinical prognosis (Renal survival) of all aHUS patients in Korea(from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, or date of ESRD diagnosis, whichever came first)
- Clinical prognosis (Overall survival) of all aHUS patients in Korea(from the first onset date of TMA diagnosed as aHUS to the last follow up (within March 31, 2022), death, whichever came first)
研究者
研究点 (1)
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