UMIN-CTR Clinical Trial

Public title

Pharmacogenomic study to predict warfarin stable dose in Japanese chidren.

Acronym

Pharmacogenomic study to predict warfarin stable dose in Japanese chidren.

Scientific Title

Pharmacogenomic study to predict warfarin stable dose in Japanese chidren.

Scientific Title:Acronym

Pharmacogenomic study to predict warfarin stable dose in Japanese chidren.

Region

Japan

Condition

congenital heart disease, Kawasaki disease, myocardiac disease, thromboembolism

Classification by specialty

Pediatrics

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

To develop a model which predict stable warfarin dose in Japanese children

Basic objectives2

Others

Basic objectives -Others

Comparison of prediction performance with previously reported prediction models

Trial characteristics_1

Confirmatory

Trial characteristics_2

Developmental phase

Phase III

Primary outcomes

warfarin stable dose

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

1

days-old

<=

Age-upper limit

18

years-old

>=

Gender

Male and Female

Key inclusion criteria

Children between 0 and 18 years of age at the time of study entry who treated with warfarin for the prevention or treatment of thromboembolism
Patients who have already reached the optimal dose of warfarin and whose warfarin dose has not been changed within 28 days prior to DNA sample collection.
Patients who have received a sufficient explanation for participation in the study and have obtained the written informed consent.

Key exclusion criteria

Patients whose warfarin dose has been changed within 28 days of the date of DNA sample collection
Pregnant women and lactating women
Patients who did not give written informed consent
Patients who regularly (at least once/week) consume vitamin K-rich foods and supplements such as natto, chlorella, green juice, and St. John's wort (Hypericum perforatum)
Patients who are judged by the attending physician to be inappropriate as subjects for this study

Target sample size

480

Name of lead principal investigator

1st name	Tohru
Middle name
Last name	Kobayashi

Organization

National Center for Child Health and Development

Division name

Department of Data Science

Zip code

157-8535

Address

2-10-1, Okura, Setagaya-ku, Tokyo, Japan

TEL

0334160181

Email

torukoba@nifty.com

Name of contact person

1st name	Tohru
Middle name
Last name	Kobayashi

Organization

National Center for Child Health and Development

Division name

Department of Data Science

Zip code

157-8535

Address

2-10-1, Okura, Setagaya-ku, Tokyo, Japan

TEL

03-3416-0181

Homepage URL

Email

torukoba@nifty.com

Institute

National Center for Child Health and Development

Institute

Department

Personal name

Organization

National Center for Child Health and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

National Center for Child Health and Development

Address

2-10-1, Okura, Setagaya-ku, Tokyo, Japan

Tel

03-3416-0181

Email

rinri@ncchd.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立成育医療研究センター(東京都)
金沢医科大学病院(石川県)
京都府立医科大学(京都府)
NTT東日本札幌病院(北海道)
富山大学(富山県)
鹿児島大学病院（鹿児島県）
東京大学医学部附属病院(東京都)
鹿児島市立病院（鹿児島県）
国立国際医療研究センター(東京都)
秋田大学医学部附属病院（秋田県）
群馬県立小児医療センター（群馬県）
福岡市立こども病院（福岡県）
東邦大学医療センター大森病院(東京都)
東京都立小児総合医療センター(東京都)
千葉県こども病院（千葉県）
日本医科大学附属病院(東京都)
慶応義塾大学病院(東京都)
北海道大学病院（北海道）
国立病院機構　長崎医療センター（長崎県）
名古屋大学医学部附属病院（愛知県）

Date of disclosure of the study information

2015

Year

11

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

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

Recruitment status

Date of protocol fixation

2015

Year

10

Month

07

Day

Date of IRB

Anticipated trial start date

2015

Year

12

Month

01

Day

Last follow-up date

2018

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Objective of the study:
To develop a model which predict stable warfarin dose in Japanese children.
Eligible criteria:
Children from 0 to 18 years old who treated with warfarin stable dose as prophylaxis or thrombolysis.
Primary outcome: Warfarin stable dose
Outcome measurements:
1. Patients Background: Gender, date of birth, blood collection date, body height, body weight, race, special diet, present or past history of hemorrhagic disease
2. Warfarin-related data: start date, target PTINR with range, PTINR at DNA sampling, reason for warfarin administration, warfarin dose (/day), the last time point of warfarin medication
3. Concomitant drugs: amiodarone, bosentan, vitamin K preparation, antibacterial agents, anti-epileptic drugs
4. Adverse event: number of events with sever bleeding and thrombosis during warfarin administration, the number of event with PTINR 4.0 or more during warfarin administration
5. Gene: CYP2C9, VKORC1, CYP4F2.
Target sample size: 480 cases

Registered date

2015

Year

10

Month

19

Day

Last modified on

2021

Year

10

Month

28

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022437