UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020902 |
|---|---|
| Receipt number | 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 20:17:18 |
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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
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
baamiyan2000@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023922
