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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000016854

Enrollment

100

Registered

2015-03-20

Start date

2015-03-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fabry disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: *Subjects who fulfill the following 1)-3) criteria 1) Japanese men or women aged 15 through 70 year at informed consent 2) Volunteers who are fully informed of and understand the objectives, procedures, and possible risks of the study and provide the written voluntary consent to participate in the study. For volunteers younger than 20 years at informed consent, Consent should be obtained from the volunteers' legal acceptable representatives in addition to the consent from the volunteers. 3) Volunteers who can claim their symptoms

Exclusion criteria

Exclusion criteria: 1)Volunteers who were diagnosed or suspected as Fabry disease 2)Volunteers with a history of receiving GLA enzyme replacement therapy (Replagal&reg; or Fabrazyme&reg;) 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

Design outcomes

Primary

Measure	Time frame
Lyso-Gb3 concentration in plasma	—

Secondary

Measure	Time frame
GLA activity in plasma	—

Countries

Japan

Contacts

Public ContactTadayasu Togawa

Meiji Pharmaceutical University Department of Functional Bioanalysis

tadayasu@my-pharm.ac.jp042-495-8992

Outcome results