JPRN-jRCT2031200420进行中（未招募）3 期
A Phase 3, Prospective, Multicenter, Double Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Eculizumab in Patients With Guillain-Barre Syndrome (GBS)
Ishida Hirokazu0 个研究点目标入组 57 人开始时间: 2021年3月12日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 57
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Participants who meet the GBS criteria.
- •- Participants who are able to run prior to onset of GBS symptoms.
- •- Participants with onset of weakness due to GBS less than 2 weeks before screening.
- •- Participants unable to walk unaided for 5 or more meters (progressively deteriorating FG3 or FG4 to FG5).
- •- Participants who are already on IVIg or deemed eligible for and who will start IVIg.
- •- Participants who can start their first dose of study drug before the end of the IVIg treatment period.
排除标准
- •- Participants who have previously received or are currently receiving treatment with complement modulators.
- •- Participants who have been administered another investigational product within 30 days or 5 half-lives (whichever is longer) prior to providing consent or are currently participating in another interventional study.
- •- Participants who have received rituximab within 12 weeks prior to screening.
- •- Participants who are being considered for or are already on plasmapheresis.
- •- Participants who have received immunosuppressive treatment during the 4 weeks prior to providing consent.
研究者
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