NCT01410903终止不适用
Immunoadsorption in Addition to the Established Therapy in Patients With Systemic Sclerosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- GWT-TUD GmbH
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- survival under immunoadsorption
研究概览
简要总结
The purpose of this study is to evaluate source data for the survival and the investigation of the preliminary efficacy of immunoadsorption in patients with severe systemic sclerosis.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •systemic sclerosis according to the ACE-criteria
- •severe pulmonary manifestation with reduced DLCO
- •signed informed consent
排除标准
- •inadequate peripheral venous access
- •participation in another clinical trial
- •heart failure
- •pronounced allergic diathesis, particularly in case of known hypersensitivity to drugs and/or materials used in the extracorporeal circuit
结局指标
主要结局
survival under immunoadsorption
时间窗: 6 months
次要结局
- survival under immunoadsorption(12 months)
- Number of Serious Adverse Events(12 months)
- change in "modified Rodnan Skin Score"(12 months)
- change in Diffusing Capacity of the Lung for Carbon Monoxide(12 months)
- change in Scleroderma Health Assenssment Questionnaire(12 months)
- change of pulmonary arterial pressure(12 months)
- reoccurrence of finger ulcers(12 months)
- healing of finger ulcers(12 months)
研究者
研究点 (2)
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