UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010863
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Keio University School of Medicine, Divison of Hematology
Institute
Department

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
URL(English) https://upload.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


Contact us.