Long-term, multicenter trial of SPP-004 in mitochondrial diseases. (MRCD Long- term Study)

Saitama Medical University Hospital0 个研究点开始时间: 待定最近更新: 2021年12月5日

试验速览

暂无简介。

•Japanese patients who meet all of the following criteria are included in this clinical trial.
•Patients participated in, and completed, an exploratory study of SPP-004 in mitochondrial diseases (study protocol no.: SPED-ALA-001)
•Patients with written informed consent from their legal representatives (persons in parental authority or guardians)

•Patients who meet any of the following criteria are excluded from this trial.
•Patients with mitochondrial cardiomyopathy
•Patients with severe cardiac function or renal function disorders
•Patients complicated by sepsis
•Patients with a history of drug allergy
•Patients with a history of hypersensitivity to any ingredients of the investigational drugs
•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)
•Patients whom the investigator and sub-investigator considered inappropriate to participating this trial

The Newcastle Paediatric Mitochondrial Disease Scale (NPMDS) Section I~III

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