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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name