EUCTR2018-003592-34-DK进行中（未招募）1 期
Subcutaneous immunoglobulin in de-novo CIDP(Randomized, parallel study of subcutaneous versus intravenous immunoglobulin in treatment-naïve patients with chronic inflammatory demyelinating polyneuropathy) - SIDEC
Aarhus University Hospital0 个研究点目标入组 60 人开始时间: 2019年3月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •Patients diagnosed with typical or pure motor CIDP fulfilling the European Federation of Neurological Societies / Peripheral Nerve Society (EFNS/PNS) clinical and elctrophysiological criteria for definite or propable CIDP
- •Age > 18 and <80 years at inclusion
- •Overall disability sum score (ODSS) > 1
- •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
- •Previous treatment with immmunoglobulin
- •Malignancies
- •Other causes of neuropathy (Diabetes Mellitus)
- •Severe medical diseases
- •Other immunomodulating treatment in the last 6 weeks prior to inclusion
- •Hepatitis B and C or HIV
研究者
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