UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030485 |
|---|---|
| Receipt number | R000034751 |
| Scientific Title | Evaluation of efficacy and risks of vaccination for liver transplant recipients |
| Date of disclosure of the study information | 2018/12/20 |
| Last modified on | 2019/12/22 12:24:48 |
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Basic information
Public title
Evaluation of efficacy and risks of vaccination for liver transplant recipients
Acronym
Vaccination for liver transplant recipients
Scientific Title
Evaluation of efficacy and risks of vaccination for liver transplant recipients
Scientific Title:Acronym
Vaccination for liver transplant recipients
Region
| Japan |
Condition
Condition
Liver transplant recipients
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy and risks of vaccination for liver transplant recipients with
immunosuppressant
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Obtain immunity from vaccination 12 months after vaccination (IgG)
Key secondary outcomes
Side effects of vaccination within 12months after vaccination
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Vaccine |
Interventions/Control_1
Vaccination for patients with
immunosuppressant
measles
rubella
mumps
varicella
each 1 time
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
| 2 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
More than 2 years after transplantation
Without steroid administration
More than 1 year with stable liver functional tests
Key exclusion criteria
Without inclusion criteria
With active infection
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | OKAJIMA |
Organization
Graduate School of Medicine
Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic surgery
Zip code
606-8507
Address
54 Kawaracho Shogoin Sakyo-ku Kyoto, JAPAN
TEL
075-751-3243
ho1962@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | OKAJIMA |
Organization
Graduate School of Medicine Kyoto University
Division name
Division of Hepato-Biliary-Pancreatic surgery
Zip code
606-8507
Address
54 Kawaracho Shogoin Sakyo-ku Kyoto, JAPAN
TEL
075-751-3243
Homepage URL
ho1962@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto Unoversity
Address
Kawaharacho-54 Shogoin Sakyo-ku Kyoto, JAPAN
Tel
075-751-3243
ho1962@kuhp.kyoto-u.ac.jp
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
| 2018 | Year | 12 | Month | 20 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 20 | Day |
Last modified on
| 2019 | Year | 12 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034751
