UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010863
Receipt number R000012717
Scientific Title The effect of CYP2C19 polymorphism on Japanese patients simultaneously receiving calcineurin inhibitor and voriconazole post hematopoietic stem cell transplant
Date of disclosure of the study information 2013/06/03
Last modified on 2013/12/03 22:02:14

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Basic information

Public title

The effect of CYP2C19 polymorphism on Japanese patients simultaneously receiving calcineurin inhibitor and voriconazole post hematopoietic stem cell transplant

Acronym

The effect of CYP2C19 polymorphism on VRCZ metabolism

Scientific Title

The effect of CYP2C19 polymorphism on Japanese patients simultaneously receiving calcineurin inhibitor and voriconazole post hematopoietic stem cell transplant

Scientific Title:Acronym

The effect of CYP2C19 polymorphism on VRCZ metabolism

Region

Japan


Condition

Condition

hematopoietic diseases

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To evaluate the effect of CYP2C19 polymorphism on the blood concentration level of calcineurin inhibitors and voriconazole in patients receiving hematopoietic stem cell transplant.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To evaluate the effect of CYP2C19 polymorphism on the blood concentration level of calcineurin inhibitors and voriconazole

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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Age over 20-years-old and less than 65-years-old at the time of obtaining informed consent
2) Patients scheduled to use calcineurin inhibitors
3) Patients who have given written informed consent before stem cell transplant

Key exclusion criteria

1) Patients with allergic reaction to calcineurin inhibitors or voriconazole
2) Any other patient, whom the treating physician has declared inappropriate for study enrollment

Target sample size

55


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichiro Okamoto

Organization

Keio University School of Medicine

Division name

Division of Hematology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

+81-3-3353-1211

Email

okamoto@a7.keio.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuya Kohda

Organization

Keio University School of Medicine

Division name

Division of Hematology

Zip code


Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

+81-3-3353-1211

Homepage URL


Email

koukouda@gmail.com


Sponsor or person

Institute

Keio University School of Medicine, Divison of Hematology

Institute

Department

Personal name



Funding Source

Organization

Japan Research Foundation for Clinical Pharmacology

Organization

Division

Category of Funding Organization

Non profit foundation

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

2013 Year 06 Month 03 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

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



Progress

Recruitment status

Enrolling by invitation

Date of protocol fixation

2013 Year 04 Month 06 Day

Date of IRB


Anticipated trial start date

2013 Year 06 Month 03 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Initiated enrollment


Management information

Registered date

2013 Year 06 Month 03 Day

Last modified on

2013 Year 12 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012717


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name