Validation study for lyso-Gb3 plasma concentration in healthy adult or child Japanese volunteers - Validation study of lyso-Gb3 plasma concentration in healthy Japanese volunteers

Meiji Pharmaceutical University0 个研究点目标入组 100 人开始时间: 2015年3月20日最近更新: 2023年10月17日

适应症

试验速览

Clin Exp Nephrol. doi: 10.1007/s10157-017-1525-3.(open access)

•1)Volunteers who were diagnosed or suspected as Fabry disease 2)Volunteers with a history of receiving GLA enzyme replacement therapy (Replagal® or Fabrazyme®) 3)Volunteers who have previous or current disease or symptoms shown in Table 3 4)Volunteers who any their relatives (parents, brothers, sisters, sons, daughters, grandparents, or cousins) have Fabry disease 5)Volunteers who received amiodarone, chloroquine or hydroxychloroquine within 6 months before informed consent or plan to receive either of the drugs during the study 6)Volunteers who are considered unhealthy (having clinical issues for which any treatments or clinical observation are necessary) by the investigator at screening 7)Volunteers who have any histories of cardiovascular, liver, kidney, lung, endocrine, digestive, blood, respiratory, neuropsychiatric, or central nervous system diseases and are considered ineligible for the study by the investigator. 8)Volunteers who are otherwise considered ineligible for the study by the investigator

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