NCT04078698已完成不适用
Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine (SEPIAR)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 6
- 主要终点
- Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN®
研究概览
简要总结
Documentation of the safety and effectiveness profile of the CE-labelled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.
详细描述
The objective of the study is the documentation of the safety and effectiveness profile of the CE-labeled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.
The primary objective for the IgG adsorber GLOBAFFIN® is the estimation of the mean relative reduction in total IgG from pre- to post-treatment per treatment session.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum age of 18 years
- •Informed consent signed and dated by study patient and investigator/authorised physician
- •Ability to understand the nature and requirements of the study
- •Treatment with one of the immunoadsorber system GLOBAFFIN® according to the intended use.
排除标准
- •Any condition which could interfere with the patient's ability to comply with the study
- •In case of female patients: pregnancy or lactation period (if patient is ≥ 55 years old or have been surgically sterilized, a negative pregnancy test is not required)
- •Participation in an interventional clinical study during the preceding 30 days.
- •Participation in an interventional clinical study with pharmacological active substances (e.g. therapeutic antibodies) during the preceding 60 days.
- •Any deviation from the intended use
- •Study-specific:
- •Any contraindication listed in the valid instruction for use:
- •Hypersensitivity or allergy against any materials used in either the immunoadsorber column or the extracorporeal circuit
- •Inability to withstand the stress of an extracorporeal treatment procedure due to their age, their physical developments or their clinical constitution
- •Previously demonstrated hypersensitivity associated with therapeutic apheresis
- •No suitable anticoagulation treatment, such as due to known hypersensitivity to heparin or ACD-A
- •Haemorrhagic diathesis in which extracorporeal apheresis procedures and anticoagulation performed have a high bleeding hazard
- •Severe cardiovascular disease, so that extracorporeal treatment is not possible
- •Acute, systemic infection
结局指标
主要结局
Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN®
时间窗: 5 years
次要结局
- Mean relative reduction in disease-specific IgG, total IgM and total IgA(5 years)
- Clinical effect of the treatment measured by the physician's judgement as well as indication specific scores(5 years)
研究者
研究点 (6)
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