EUCTR2013-003589-15-GB进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •- Male or female subjects =18 years old
- •- Diagnosis of MG
- •- MGFA Clinical Classification Class II to IV at screening
- •- MG-ADL total score must be =6 at screening and randomization
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 83
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •- History of thymoma or other neoplasms of thymus
- •- History of thymectomy within 12 months prior to screening
- •- Weakness only affecting ocular or peri-ocular muscles (MGFA Class I)
- •- MG crisis at screening (MGFA Class V)
- •- Pregnancy or lactation
- •- Unresolved meningococcal infection
研究者
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