NCT05177939招募中3 期
Phase III Study to Evaluate the Efficacy and Safety of NPB-01 in Patients With Autoimmune Encephalitis Refractory to Steroid Pulse Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Proportion of responders in CASE (Clinical Assessment Scale in Autoimmune Encephalitis)
研究概览
简要总结
To compare the efficacy and safety of NPB-01 in patients with autoimmune encephalitis refractory to steroid pulse therapy using steroid pulse therapy as a control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •< At 1st registration > Patients with strongly suspected infectious encephalitis
- •< At 1st registration > Patients who received immunoglobulin preparations within 8 weeks prior to informed consent
- •< At 1st registration > Patients who received plasma exchange within 4 weeks prior to informed consent
- •< At 1st registration > Patients who received immunosuppressants (Rituximab, cyclophosphamide, etc.) within 4 weeks prior to informed consent
- •< At 1st registration > Patients who have had tumor resection associated with autoimmune encephalitis within 4 weeks prior to informed consent
- •< At 1st registration > Patients with a history of shock or hypersensitivity to the ingredients of NPB-01
- •< At 1st registration > Patients with known IgA deficiency
- •< At 1st registration > Patients with renal disorder
- •< At 1st registration > Patients with a current or previous history of cerebral or cardiovascular disorders (Asymptomatic cerebral infarction and myocardial infarction that occurred more than 5 years ago are not applicable.)
- •< At 1st registration > Patients at high risk of thromboembolism
- •< At 1st registration > Patients with haemolytic/blood loss anaemia
- •< At 1st registration > Immunosuppressed/immunocompromised patients
- •< At 1st registration > Patients with decreased cardiac function
- •< At 1st registration > Pregnant, expected (desired or planned) pregnant, or breastfeeding patients
- •< At 1st registration > Use of prohibited medications or treatment in this study
- •< At 1st registration > Patients who received investigational product in this study (re-enrollment prohibited)
- •< At 1st registration > Patients who have received treatment with investigational product other than this study within 4 months prior to informed consent
- •< At 1st registration > Patients with a history of hypersensitivity to methylprednisolone sodium succinate
- •< At 1st registration > Patients who have a tumor associated with autoimmune encephalitis and are considered to require resection during the study period.
- •< At 1st registration > Patients receiving intravenous general anesthetics or sedative hypnotics
- •< At 1st registration > Patients in coma
- •< At 1st registration > Ventilated patients
- •< At 1st registration > Patients who cannot undergo protocol-specified tests/assessments
- •< At 1st registration > Other patients considered ineligible for the study by the investigator
- •< At 2nd registration > Positive herpes simplex virus DNA qualitative test in the screening period.
- •< At 2nd registration > Serum creatinine ≥ 2 times the upper limit of normal during the screening period.
- •< At 2nd registration > Total protein ≥ 9 g/dL during the screening period.
- •< At 2nd registration > Patients with hematocrit ≥ 55% during the screening period
- •< At 2nd registration > Patients who meet any of the exclusion criteria at the time of first registration
研究组 & 干预措施
NPB-01
Experimental
Intravenous immunoglobulin
干预措施: NPB-01 (Drug)
NPB-01-ME
Active Comparator
methylprednisolone sodium succinate
干预措施: NPB-01-ME (Drug)
结局指标
主要结局
Proportion of responders in CASE (Clinical Assessment Scale in Autoimmune Encephalitis)
时间窗: 4 weeks
A responder is defined as a patient whose CASE score at Week 4 of the post-treatment follow-up period after treatment with investigational product improved by 40% or more compared to the pre-treatment period.
次要结局
- CASE(1, 2, 3, 4, 6, 8, 12 weeks)
- MMSE-J(4, 8, 12 weeks)
- mRS(1, 2, 3, 4, 6, 8, 12 weeks)
- GCS(1, 2, 3, 4, 6, 8, 12 weeks)
- FAB(4, 8, 12 weeks)
- Duration of hospitalization(12 weeks)
- Disappearance of abnormal EEG findings(4, 12 weeks)
- Disappearance of abnormal head MRI findings(4, 12 weeks)
- Cerebrospinal fluid test(4, 12 weeks)
- mRS proportion(1, 2, 3, 4, 6, 8, 12 weeks)
- GCS proportion(1, 2, 3, 4, 6, 8, 12 weeks)
研究者
研究点 (1)
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