Effect of Erythropoietin in Refractory Autoimmune Encephalitis Patients
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Change from Baseline modified Rankin Scale (mRS) at 12th week
研究概览
简要总结
This study evaluates the efficacy of erythropoietin in refractory autoimmune encephalitis. Ten patients will receive 100 IU/kg of erythropoietin 3 times a week for 12 weeks.
详细描述
Erythropoietin can improve the refractory autoimmune encephalitis. Erythropoietin has tissue-protective effect via activation of Janus kinase (JAK)-2, signal transducer and activator of transcription (STAT)-5 pathway and NF-kappa B pathway. The activation of JAK-2 and STAT-5 promote hemoglobin synthesis and facilitate cell cycle progression. Also, NF-kappa B pathway inhibition regulates pro-inflammatory cytokine production.
We expect that erythropoietin may lead to improve the symptoms and outcome of autoimmune encephalitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed autoimmune encephalitis
- •Ineffective 1st line treatment (e.g. steroid IV, IVIg) and 2nd line treatment (e.g. Rituximab or cyclophosphamide)
排除标准
- •Hemoglobin > 12g/dL
- •Hematochrit >36%
- •Thrombocytosis > 750K
- •AST or ALT > 120
- •Allergic reaction upon erythropoietin
- •Uncontrolled hypertension
- •mRS before the autoimmune encephalitis > 3
- •Breast feeding or pregnancy
- •History of ischemic stroke or pulmonary thrombosis
- •Refuse to be enrolled
研究组 & 干预措施
EPO
Erythropoietin injection: three times per a week, 100 IU/kg for each patients Trade name: epokine prefilled injection
干预措施: Erythropoietin (Drug)
结局指标
主要结局
Change from Baseline modified Rankin Scale (mRS) at 12th week
时间窗: 2nd week, 12th week
Favorable outcome is an improvement of mRS score.
次要结局
- Adverse effect(2nd week, 4th week, 8th week, 12th week)
- Quality of Life in Epilepsy Inventory (QOLIE) -31(2nd week, 4th week, 8th week, 12th week)
- Mini-Mental State Examination (MMSE)(2nd week, 4th week, 8th week, 12th week)
研究者
Kon Chu
Associate Professor
Seoul National University Hospital