NCT02221271已完成3 期
Phase III Clinical Trial of NPB-01 in Patients With Guillain-Barré Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks.
研究概览
简要总结
Patients diagnosed with Guillain-Barré syndrome were confirmed based on the diagnostic criteria for Guillain-Barré syndrome. 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.
Patients evaluate the Functional Grade（FG） and Arm Grade（AG） et al.
As a safety endpoint, the safety of NPB-01 will be investigated the occurrence of adverse events by 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In principle, patients are able to receive study drug within 2weeks(with limits of 4weeks) from the start of symptoms.
- •Patients with predominant motor neuropathy and Hughes's Functional Grade(FG) is grade4 or grade5(in this regard, if symptoms is progressive, patients with FG is grade3 involve in this study).
- •Patients with plasmapheresis, steroids(in prednisolone equivalent, more than 100mg/day) and immune globulin therapy is no operation for this onset.
- •Patients with greater than or equal to 18 years old at informed consent.
排除标准
- •Patients with history of shock for NPB-
- •Patients with history of hypersensitivity for NPB-
- •Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, tephromyelitis, botulism, hysterical paralysis, toxic neuropathy(nitrofurantoin, dapsone, organophosphorous compound), serious diabetic neuropathy,peripheral neuropathy due to HIV,impaired peripheral neuropathy except Guillain-Barré syndrome.
- •Patients with malignancy at informed consent.
- •Patients treated with immune globulin at 8 weeks before informed consent.
- •Patients with IgA deficiency.
- •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
Experimental
干预措施: NPB-01 (Drug)
结局指标
主要结局
proportion of patients with more than 1grade improvement in the Hughes functional grading scale(FG) relative to baseline at 4weeks.
时间窗: Baseline,4weeks
次要结局
- days required for 1 grade improvement of the Hughes functional grading scale(FG)(Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks)
- days required for 2 grade improvement of the Hughes functional grading scale(FG)(Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks)
- changes in grip strength(Baseline,1,2,3,4,8,12 weeks)
- changes in activity of daily living(ADL)(Baseline,1,2,3,4,8,12 weeks)
- proportion of patients with more than 1 grade improvement in the Arm Grade(AG) relative to baseline at 4weeks.(Baseline,4weeks)
- days required for 1 grade improvement of the Arm Grade(AG)(Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks)
- days required for 2 grade improvement of the Arm Grade(AG)(Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks)
- changes in Arm Grade(AG)(Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks)
- changes in manual muscle testing(MMT)(Baseline,1,2,3,4,8,12 weeks)
- changes in electrophysiological findings(Baseline,4,12 weeks)
- changes in Hughes functional grading scale(FG)(Baseline,1,2,3,4,5,6,7,8,9,10,11,12 weeks)
研究者
研究点 (1)
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