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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016854
Receipt No. R000019564
Scientific Title Validation study for lyso-Gb3 plasma concentration in healthy adult or child Japanese volunteers
Date of disclosure of the study information 2015/03/20
Last modified on 2018/02/22

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Basic information
Public title Validation study for lyso-Gb3 plasma concentration in healthy adult or child Japanese volunteers
Acronym Validation study of lyso-Gb3 plasma concentration in healthy Japanese volunteers
Scientific Title Validation study for lyso-Gb3 plasma concentration in healthy adult or child Japanese volunteers
Scientific Title:Acronym Validation study of lyso-Gb3 plasma concentration in healthy Japanese volunteers
Region
Japan

Condition
Condition Fabry disease
Classification by specialty
Medicine in general Gastroenterology Cardiology
Endocrinology and Metabolism Nephrology Neurology
Ophthalmology Dermatology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To investigate the reference range of plasma Lyso-Gb3 in healthy adult or child Japanese volunteers
Basic objectives2 Others
Basic objectives -Others To investigate the reference range of plasma Lyso-Gb3 for the diagnosis of Fabry disease
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Lyso-Gb3 concentration in plasma
Key secondary outcomes GLA activity in plasma

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
15 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key 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
Key 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
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hitoshi Sakuraba
Organization Meiji Pharmaceutical University
Division name Department of Clinical Genetics
Zip code
Address 2-522-1 Noshio,Kiyose City Tokyo 204-8588,Japan
TEL 042-495-8923
Email sakuraba@my-pharm.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tadayasu Togawa
Organization Meiji Pharmaceutical University
Division name Department of Functional Bioanalysis
Zip code
Address 2-522-1 Noshio,Kiyose City Tokyo 204-8588,Japan
TEL 042-495-8992
Homepage URL
Email tadayasu@my-pharm.ac.jp

Sponsor
Institute Meiji Pharmaceutical University
Institute
Department

Funding Source
Organization Sumitomo Dainippon Pharma Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions シーピーシー治験病院(鹿児島県)/ CPC Clinical Trial Hospital (KAGOSHIMA)

Other administrative information
Date of disclosure of the study information
2015 Year 03 Month 20 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Clin Exp Nephrol.  doi: 10.1007/s10157-017-1525-3.(open access)
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 03 Month 17 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2015 Year 03 Month 20 Day
Last modified on
2018 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019564

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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