UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000259 |
|---|---|
| Receipt number | R000000323 |
| 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 |
| Date of disclosure of the study information | 2005/10/17 |
| Last modified on | 2008/04/08 09:35:45 |
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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
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
Sponsor or person
Institute
The Artificial Organ and Transplantation Division, Department of Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000323
