CTIS2024-514494-21-00进行中（未招募）1 期
A Multicenter Randomized, Controlled, Double-blinded Trial to Evaluate Efficacy and Safety of Bortezomib in Patients With Severe Autoimmune Encephalitis - ZKSJ0120
Friedrich-Schiller-Universitaet Jena0 个研究点目标入组 50 人开始时间: 2024年6月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Clinically diagnosed severe autoimmune encephalitis (defined as mRS = 3), Autoantibodies against neuronal surface proteins in cerebrospinal fluid or serum serum, detection must not be older than 4 weeks, calculated before randomization, Pre-treatment with rituximab, Age = 18 years, Written informed consent of the patient or the patient under witness” (if the patient cannot write for motor reasons) cannot write themselves) or the legal representative (=guardian) or the authorized representative, Potentially fertile patient (up to 2 years after menopause): negative pregnancy test
排除标准
- •Lactation, Acute infiltrative lung disease, Acute infiltrative pericardial disease, Malignant tumor under ongoing or newly started chemotherapy, Concurrent participation in another intervention study, Previous participation in this study, Known hypersensitivity to any ingredient of the investigational product, Continued therapy with glucocorticoids/rituximab during the duration of the study (last administration must be completed before first administration of investigational product)
研究者
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