NCT00309101已完成3 期
FK506 Phase 3 Study: An Open Study for Steroid Resistant, Non-Thymectomized MG Patients
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
- 11
- 主要终点
- Improvement of clinical symptoms
研究概览
简要总结
The purpose of the study is to investigate the efficacy and safety for steroid resistant, non-thymectomized MG patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed as myasthenia gravis
- •Those whose MG symptoms are not controlled by the treatment with prednisone
排除标准
- •Those who had undergone thymectomy
研究组 & 干预措施
1. tacrolimus
Experimental
干预措施: tacrolimus (Drug)
结局指标
主要结局
Improvement of clinical symptoms
时间窗: 28 Weeks
次要结局
- Improvement of daily activity(28 Weeks)
研究者
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