NCT00515450已完成3 期
A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis
Benesis Corporation2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2007年7月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Changes in QMG score
研究概览
简要总结
This randomized controlled, multi-center study will carry out to assess the efficacy of GB-0998 compared to plasmapheresis in the treatment of the generalized Myasthenia Gravis based on the changes in Quantitative Myasthenia Gravis score (QMG score) 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
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
- •Patients diagnosed as generalized myasthenia gravis
- •Patients who are not controlled by current therapy and need plasmapheresis therapy
- •Patients who have the high-dose steroid therapy for over a month in past years, and also who take steroid or immunosuppressant on the day of consent
- •Patients who had not any dose increase or new dosing of steroid or immunosuppressant within 4 weeks prior to enrollment
排除标准
- •Patients who received steroid pulse therapy, globulin therapy or plasmapheresis therapy within 12 weeks prior to enrollment
- •Patients who had undergone thymectomy within 24 weeks prior to enrollment
- •Patients with 3 points item in bulbar symptom of MG-ADL scale
- •Patients with severe hepatic disorder, severe renal disorder or severe heat disorder
- •Patients who have received treatment of malignant tumors
- •Patients who have the anamnesis of shock or hypersensitivity to this drug
- •Patients who have been diagnosed as hereditary fructose intolerance
- •Patients who have the anamnesis of cerebral infarction or symptom of these diseases
- •Patients who have been diagnosed as IgA deficiency in their past history
- •Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant
- •Patients who were administered other investigational drug within 12 weeks before consent
结局指标
主要结局
Changes in QMG score
时间窗: at 4 weeks
次要结局
- Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels(from beginning of the treatment through 4th week)
研究者
研究点 (2)
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