NPB-01(Intravenous Immunoglobulin) Maintenance Therapy for Patients With Chronic Inflammatory Demyelinating Polyneuropathy.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks.
研究概览
简要总结
Patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy 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 Inflammatory Neuropathy Cause and Treatment（INCAT） score and INCAT sensory sumscore（ISS） 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 with progressive or relapsing motor and sensory dysfunction of more than one limb resulting from neuropathy within 2 months prior to the date informed consent is obtained.
- •Patients who INCAT score between 2-
- •(If the INCAT score is 1 in upper limb, the INCAT score of 2 must be exclusively from leg disability to qualify.)
- •Patients who need high-dose intravenous immunoglobulin therapy.
- •Patients who continued treatment for CIDP without addition or increase at 30 days before informed consent.
- •Patients with greater than or equal to twenty years old at informed consent.
排除标准
- •Patients with evidence of myelopathy or demyelination of central nerve
- •Patients with evidence of stroke, central nerve system trauma, or persistent neurological deficits due to peripheral neuropathy from other causes（diabetic neuropathy, IgM paraproteinaemia, uraemic neuropathy, toxic neuropathy, hereditary neuropathy）
- •Patients with evidence of neuropathy or alcoholic neuropathy or vitamin deficiency neuropathy due to myeloma, lymphoma, sarcoidosis, systemic lupus erythematosus, malignancy, vasculitis, Crow-Fukase syndrome, Sjögren syndrome.
- •Patients with multifocal motor neuropathy.
- •Patients treated with plasmapheresis at 3 months before informed consent.
- •Patients treated with rituximab 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 at informed consent.
- •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
proportion of patients with more than 1point improvement in the INCAT score relative to baseline at 28weeks.
时间窗: 28weeks
proportion of patients with more than 1point exacerbation in the INCAT score relative to 28weeks at 52weeks.
时间窗: 52weeks
次要结局
- maximum grip strength(1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks)
- Medical Research Council（MRC） sum score(1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks)
- the amplitude of the compound muscle action potential of the most severely affected motor nerve(1,4,28,52weeks)
- INCAT score(1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks)
- ISS(1,4,7,10,13,16,19,22,25,28,31,34,37,40,43,46,49,52weeks)