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临床试验/EUCTR2013-005363-52-NL
EUCTR2013-005363-52-NL进行中(未招募)不适用

Intravenous immunoglobulin overtreatment in chronic inflammatory demyelinating polyneuropathy (CIDP)

Department of Neurology, Academic Medical Center0 个研究点开始时间: 2014年3月27日最近更新:
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1) Probable or definite CIDP according to the EFNS/PNS criteria 20103
  • 2) Stable disease for 6 months (e.g. no progression of disease in last 6 months)
  • 3) IVIg treatment for at least 6 months
  • 4) IVIg infusion interval of 2 to 6 weeks.
  • 5) Age > 18 years
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 50
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 10

排除标准

  • 1) Deterioration after IVIg withdrawal in the last 12 months
  • 2) Changes in IVIg treatment dose/interval in last 6 months
  • 3) Change of additional CIDP treatment, if any, in the last 3 months (e.g. corticosteroids or immunosuppressive treatment)
  • 4) A prolonged period (> 6 weeks) of disability increase following an earlier IVIg withdrawal attempt
  • 5) History of respiratory failure related to CIDP
  • 6) Legally incompetent
  • 7) Lack of written informed consent

研究者

发起方
Department of Neurology, Academic Medical Center

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