NCT02342184已完成3 期
Efficacy and Safety Study of GB-0998 for 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
- 21
- 试验地点
- 1
- 主要终点
- Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG)
研究概览
简要总结
This study will carry out to assess the efficacy of GB-0998 (intravenous immunoglobulin;400mg/kg/day for five days) in the treatment of the Guillain-Barré Syndrome based on the changes in Hughes Functional Grade (FG) as primary endpoint, and in addition, to assess the safety of GB-0998.
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
- 16 Years 至 —（Child, 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 the treatment within 2 weeks (with limits of 4 weeks) from the start of symptoms.
- •Patients with predominant motor neuropathy and FG is grade 4 or grade 5 (if symptoms is progressive, patients with FG is grade 3 involve in this study).
- •Patients with plasmapheresis, steroids and immune globulin therapy is no operation for this onset.
排除标准
- •Patients who have the anamnesis of shock or hypersensitivity to GB-
- •Patients who have been diagnosed as hereditary fructose intolerance.
- •Patients who have impaired peripheral neuropathy except Guillain-Barré syndrome.
- •Patients with history of volatile organic solvent abuse, abnormal porphyrin metabolism, history of pharynx or cutaneous diphtheria, plumbism, poliomyelitis, botulism, hysterical paralysis, toxic neuropathy.
- •Patients who have received treatment of malignant tumors.
- •Patients who were administered immunoglobulin within 8 weeks before informed consent.
- •Patients who have been diagnosed IgA deficiency in their past history.
- •Patients with severe renal disorder or decreased cardiac function.
- •Patients who have the anamnesis of cerebro- or cardiovascular disorders, or symptom of these diseases.
- •Patients with high risk of thromboembolism.
- •Pregnant, lactating, and probably pregnant patients.
- •Patients who were administered other investigational drug within 12 weeks before consent.
研究组 & 干预措施
GB-0998
Experimental
干预措施: GB-0998 (Drug)
结局指标
主要结局
Proportion of patients with more than 1 grade improvement in Hughes Functional Grade (FG)
时间窗: 4 weeks
次要结局
- changes in activity of daily living (ADL)(1,2,4,8,12 weeks)
- days required for 2 grade improvement of the AG(1,2,3,4,6,8,12 weeks)
- changes in grip strength(1,2,4,8,12 weeks)
- changes in motor nerve conduction velocity(4,12 weeks)
- days required for 1 grade improvement of the AG(1,2,3,4,6,8,12 weeks)
- changes in AG(1,2,3,4,6,8,12 weeks)
- days required for 1 grade improvement of FG(1,2,3,4,6,8,12 weeks)
- proportion of patients with more than 1 grade improvement in the Arm Grade (AG) relative to baseline(4weeks)
- changes in manual muscle testing (MMT)(1,2,4,8,12 weeks)
- days required for 2 grade improvement of FG(1,2,3,4,6,8,12 weeks)
- changes in FG(1,2,3,4,6,8,12 weeks)
- changes in FG on rescue treatment(1,2,3,4,6,8,12 weeks)
研究者
研究点 (1)
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