NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Multifocal Motor Neuropathy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- maximum grip strength
研究概览
简要总结
Patients diagnosed with Multifocal Motor Neuropathy were confirmed based on the European Federation of Neurological Societies/ Peripheral. Nerve Society Guideline. Patients who meet all inclusion criteria and do not conflict with the exclusion criteria will receive NPB-01 (intravenous immunoglobulin) 400mg/kg/day for five consecutive days. Subsequently, patients receive NPB-01 1g/kg every 3weeks and evaluate the Medical Research Council（MRC） score and the Guy's Neurological Disability Scale（GNDS） et al.
As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by one year after the start of the study treatment.
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
- 20 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who need high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） therapy.
- •Patients who continued treatment for MMN without addition or increase at 30 days before informed consent.
- •Patients who MRC score increased 1 stage in greater than or equal to 2 muscles and not decreased relative other muscles to before at after in high-dose intravenous immunoglobulin therapy.
- •Patients with greater than or equal to twenty years old at informed consent.
排除标准
- •Patients treated with Plasmapheresis at 3 months before informed consent.
- •Patients treated with Rituximab or Natalizumab at 6 months before informed consent.
- •Patients treated with Interferon-beta at 6 months before informed consent.
- •Patients treated with high-dose intravenous immunoglobulin（greater than or equal to 1g/kg） at 8 weeks before informed consent.
- •Patients treated with intravenous immunoglobulin at 3 weeks before informed consent.
- •Patients with history of shock or hypersensitivity for NPB-
- •Patients with IgA deficiency.
- •Patients with malignancy.
- •Patients with impaired liver function.
- •Patients with impaired renal function.
- •Patients with cerebro- or cardiovascular disorders.
- •Patients with high risk of thromboembolism.
- •Patients with hemolytic/hemorrhagic anemia.
- •Patients with decreased cardiac function.
- •Patients with decreased platelet.
研究组 & 干预措施
NPB-01
Intravenous immunoglobulin
干预措施: NPB-01 (Drug)
结局指标
主要结局
maximum grip strength
时间窗: 49 weeks
Medical Research Council（MRC） score
时间窗: 49 weeks
The Guy's Neurological Disability Scale (GDNS)
时间窗: 49 weeks
次要结局
未报告次要终点