EUCTR2011-003448-28-AT进行中（未招募）不适用
Randomized, multicenter, double-blind, placebo-controlled, parallel-group phase III study to investigate the efficacy, safety, and tolerability of 2 different doses of IgPro20 (subcutaneous immunoglobulin) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) – the PATH study - PATH
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
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. Definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria 2010.
- •2. Repeated treatment with IVIG (= 4 infusions) within the last 9 months prior to enrollment.
- •3. An IVIG treatment during the last 8 weeks prior to enrollment.
- •4. Age =18 years.
- •5. Written informed consent for study participation obtained before undergoing any study-specific procedures.
- •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 225
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Any polyneuropathy of other causes
- •2. Any other disease (mainly neurological or chronic orthopedic) that has caused neurological symptoms or may interfere with treatment or outcome assessments
- •3. Severe diseases and conditions that are likely to interfere with evaluation of the study product or satisfactory conduct of the study
- •4. History of thrombotic episodes within the 2 years prior to enrolment
- •5. Known allergic or other severe reactions to blood products including intolerability to previous IVIG
研究者
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