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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020902
Receipt No. R000023922
Scientific Title Warfarin sensitivity-related gene polymorphism (SNPs) in Japanese pediatric patients
Date of disclosure of the study information 2016/02/10
Last modified on 2017/12/18

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Basic information
Public title Warfarin sensitivity-related gene polymorphism (SNPs) in Japanese pediatric patients
Acronym Warfarin sensitivity-related gene polymorphism-SNPs-W
Scientific Title Warfarin sensitivity-related gene polymorphism (SNPs) in Japanese pediatric patients
Scientific Title:Acronym Warfarin sensitivity-related gene polymorphism-SNPs-W
Region
Japan

Condition
Condition congenital heart disease, Kawasaki disease, myocardiac disease
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify the relation between SNPs involved in warfarin metabolism, warfarin dose and side effects in warfarin-treated patients.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes optimal warfarin dose and side effects
Key secondary outcomes

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
0 years-old <=
Age-upper limit
19 years-old >=
Gender Male and Female
Key inclusion criteria Patients who were treated with warfarin for 3 or more months, and have undergone PT-INR evaluation 3 times or more in this period
Key exclusion criteria Patients who decline a written informed consent.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Wakamiya Takuya
Organization Yokohama City University School of Medicine
Division name Department of Pediatric Cardiology
Zip code
Address 3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa , Japan
TEL 045-787-2800
Email baamiyan2000@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Wakamiya Takuya
Organization Yokohama City University School of Medicine
Division name Department of Pediatric Cardiology
Zip code
Address 3-9 Fukuura, Kanazawaku, Yokohama, Kanagawa , Japan
TEL 045-787-2800
Homepage URL
Email baamiyan2000@yahoo.co.jp

Sponsor
Institute Yokohama City University School of Medicine
Institute
Department

Funding Source
Organization Yokohama City University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 10 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
Patients with the TT genotype in rs9923231 in VKORC1 required significantly lower maintenance dosages than those with the TC genotype (p = 0.001). 
Multiple regression analysis showed that, while VKORC1 status and patient height account for  the variability in maintenance warfarin dosage
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
2014 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2016 Year 06 Month 07 Day
Date of closure to data entry
2016 Year 06 Month 07 Day
Date trial data considered complete
2016 Year 06 Month 07 Day
Date analysis concluded
2016 Year 06 Month 07 Day

Other
Other related information nothing special

Management information
Registered date
2016 Year 02 Month 05 Day
Last modified on
2017 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023922

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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