DRKS00017497招募中2 期
A multicenter randomized, controlled, double-blinded trial to evaluate efficacy and safety of bortezomib in patients with severe autoimmune encephalitis - Generate-Boost
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Clinical diagnosed severe autoimmune encephalitis (mRS = 3)
- •auto-antibodies against neuronal surface proteins in the liquor or serum, proof not older than 4 weeks prior to randomisation
- •pretreatment with Rituximab
- •Age =18 Jahre
- •signed informed consent
- •women of childbearing potential (up to 2 years after menopause): negative pregnancy test
排除标准
- •breast-feeding
- •acute infiltrative pulmonary disease
- •acute infiltrative pericardial disease
- •malignant tumor and current chemotherapy
- •current participation in another interventional study
- •previous participation in this study
- •known hypersensitivity to an ingredient of the investigational product
- •continued therapy with glucocorticoids / Rituximab during the study (last administration must be prior to the first dose of the investigational product)
研究者
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