UMIN-CTR Clinical Trial

Basic information
Public title	Prophylaxis against de novo hepatitis B or hepatitis B recurrence by vaccination for living-donor liver transplant recipients with hepatitis B-related disease: a pilot study
Acronym	HBV vaccination for LDLT recipients
Scientific Title	Prophylaxis against de novo hepatitis B or hepatitis B recurrence by vaccination for living-donor liver transplant recipients with hepatitis B-related disease: a pilot study
Scientific Title:Acronym	HBV vaccination for LDLT recipients
Region	Japan

Condition
Condition	Hepatitis B, Living-donor liver transplantation recipient
Classification by specialty	Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effectiveness of hepatitis B vaccination after living-donor liver transplantation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Acquisition rate of active immunity following hepatitis B vaccination
Key secondary outcomes	Dose reduction of anti-HBs immunoglobulin infusion after active immunization

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	Hepatitis B vaccine
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Living-donor liver transplantation recipient for hepatitis B related diseases. Living-donor liver transplantation recipient who received a graft from hepatitis B core antibody positive donor. Patients on prophylactic HBIG monotherapy. Negative for hepatitis B surface antigen, hepatitis e antigen, and hepatitis B virus DNA.
Key exclusion criteria	Positive for hepatitis C virus or human immunodeficiency virus. Patients on prophylactic lamivudine therapy.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuhiko Sugawara
Organization	University of Tokyo Hospital
Division name	The Artificial Organ and Transplantation Division, Department of Surgery
Zip code
Address	Hongo 7-3-1, Bunkyo-ku,
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Noriyo Yamashiki
Organization	University of Tokyo Hospital
Division name	The Artificial Organ and Transplantation Division, Department of Surgery
Zip code
Address	Hongo 7-3-1, Bunkyo-ku,
TEL	03-3815-5411
Homepage URL
Email

Sponsor
Institute	The Artificial Organ and Transplantation Division, Department of Surgery
Institute
Department

Funding Source
Organization	The Artificial Organ and Transplantation Division, Department of Surgery
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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	2005 Year 10 Month 17 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	Completed
Date of protocol fixation	2005 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date	2005 Year 10 Month 01 Day
Last follow-up date	2008 Year 04 Month 01 Day
Date of closure to data entry	2008 Year 04 Month 01 Day
Date trial data considered complete	2008 Year 04 Month 01 Day
Date analysis concluded	2008 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date	2005 Year 10 Month 04 Day
Last modified on	2008 Year 04 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000323

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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