JPRN-UMIN000018171已完成2 期
A prospective, multicenter, Phase II study to evaluate the safety and efficacy of eculizumab in subjects with Guillain-Barre syndrome - Japanese Eculizumab Trial for GBS:JET-GBS
Chiba University, Graduate School of Medicine Department of Neurology0 个研究点目标入组 33 人开始时间: 2015年7月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 33
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
- 18years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1.Patients who are being considered for or are already on plasmapheresis. 2.Patients who are pregnant or lactating. 3.Patients showing clear clinical evidence of peripheral polyneuropathy other than GBS, e.g. diabetic (except for mild sensory disturbance) or severe vitamin B1 deficiency related. 4.Patients who have received immunosuppressive treatment (e.g. azathioprine, cyclosporine, tacrolimus, or >20 mg prednisolone daily) during the 4 weeks prior to providing consent. 5.Patients who are known to have severe concurrent disease (such as malignancy with uncontrolled primary tumors or metastatic lesions, severe cardiovascular disease, severe COPD, or TB). 6.Patients who are unable to comply with study procedures and the treatment regimen. 7.Patients who have received rituximab within 24 weeks prior to providing consent. 8.Patients with a history of or unresolved Neisseria meningitides. 9.Patients with active infectious diseases determined to be clinically severe by the principal investigator or sub-investigator that are not being appropriately treated with antibiotics. 10.Patients who that cannot be treated with antibiotic prophylaxis due to allergies. 11.Patients who are allergic to eculizumab. 12.Patients who are known to have or are suspected of having hereditary complement deficiencies. 13.Patients who have been administered another investigational product within 12 weeks prior to providing consent or are currently participating in another trial. 14.Patients with any condition that, in the opinion of the principal investigator or sub-investigator, could increase the patient's risk by participating in the study or confound the outcome of the study. 15.Patients who have a history of Eculizumab treatment for GBS.
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