JPRN-jRCT2061210070尚未招募3 期
Phase III Study to Evaluate the Efficacy and Safety of NPB-01 in Patients With Autoimmune Encephalitis Refractory to Steroid Pulse Therapy (Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group Study)
Ota Mamoru0 个研究点目标入组 40 人开始时间: 2022年1月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
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
- >= 15age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Patients aged 15 years or older at the time of informed consent
- •2) Patients who meet any of the following (1) to (6):
- •(1) Definite diagnostic criteria for autoimmune limbic encephalitis
- •(2) MRI evidence of demyelination (probable autoimmune encephalitis)
- •(3) Probabilistic diagnostic criteria for anti-NMDAR encephalitis
- •(4) Probabilistic diagnostic criteria for Bickerstaff brainstem encephalitis
- •(5) Probabilistic diagnostic criteria for Hashimoto's encephalopathy
- •(6) Diagnostic Criteria for Autoimmune Encephalitis with Negative but Probable Autoantibodies
- •3) CASE score of 5 to 22
- •4) Patients who have had an inadequate response to steroid pulse therapy
排除标准
- •1) Patients with strongly suspected infectious encephalitis
- •2) Patients who received immunoglobulin preparations within 8 weeks prior to informed consent
- •3) Patients who received plasma exchange within 4 weeks prior to informed consent
- •4) Patients who received immunosuppressants (Rituximab, cyclophosphamide, etc.) within 4 weeks prior to informed consent
- •5) Patients who have had tumor resection associated with autoimmune encephalitis within 4 weeks prior to informed consent
- •6) Patients with a history of shock or hypersensitivity to the ingredients of NPB-01
- •7) Patients with known IgA deficiency
- •8) Patients with renal disorder
- •9) 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.)
- •10) Patients at high risk of thromboembolism
- •11) Patients with haemolytic/blood loss anaemia
- •12) Immunosuppressed/immunocompromised patients
- •13) Patients with decreased cardiac function
- •14) Pregnant, expected (desired or planned) pregnant, or breastfeeding patients
- •15) Use of prohibited medications or treatment in this study
- •16) Patients who received investigational product in this study (re-enrollment prohibited)
- •17) Patients who have received treatment with investigational product other than this study within 4 months prior to informed consent
- •18) Patients with a history of hypersensitivity to methylprednisolone sodium succinate
- •19) Patients who have a tumor associated with autoimmune encephalitis and are considered to require resection during the study period.
- •20) Patients receiving intravenous general anesthetics or sedative hypnotics
- •21) Patients in coma
- •22) Ventilated patients
- •23) Patients who cannot undergo protocol-specified tests/assessments
- •24) Other patients considered ineligible for the study by the investigator or subinvestigator
- •25) Positive herpes simplex virus DNA qualitative test in the screening period.
- •26) Serum creatinine 2 times or more the upper limit of normal during the screening period.
- •27) Total protein 9 g/dL or more during the screening period.
- •28) Patients with hematocrit 55% or more during the screening period
研究者
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