JPRN-jRCT2091220214已完成2 期
ong-term, multicenter trial of SPP-004 in mitochondrial diseases. - MRCD Long- term Study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 9month old 至 < 30month old（—）
- 性别
- All
入选标准
- •Japanese patients who meet all of the following criteria are included in this clinical trial.
- •1)Patients participated in, and completed, an exploratory study of SPP-004 in mitochondrial diseases (study protocol no.: SPED-ALA-001)
- •2)Patients with written informed consent from their legal representatives (persons in parental authority or guardians)
排除标准
- •Patients who meet any of the following criteria are excluded from this trial.
- •1)Patients with mitochondrial cardiomyopathy
- •2)Patients with severe cardiac function or renal function disorders
- •3)Patients complicated by sepsis
- •4)Patients with a history of drug allergy
- •5)Patients with a history of hypersensitivity to any ingredients of the investigational drugs
- •6)Patients participated in another clinical study within 12 weeks prior to the informed consent, except those who participated in the exploratory study of SPP-004 in mitochondrial diseases (study protocol no.SPED-ALA-001)
- •7)Patients whom the investigator and sub-investigator considered inappropriate to participating this trial
研究者
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