UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009491 |
|---|---|
| Receipt number | R000011151 |
| Scientific Title | Prospective study for Investigation and prevention for HBV reactivation |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2022/06/14 09:19:44 |
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Basic information
Public title
Prospective study for Investigation and prevention for HBV reactivation
Acronym
HBV reactivation study
Scientific Title
Prospective study for Investigation and prevention for HBV reactivation
Scientific Title:Acronym
HBV reactivation study
Region
| Japan |
Condition
Condition
HBV carrier, Past HBV infection
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Clinical immunology | Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Investigation for frequency of HBV reactivation. Evaluation for preventive effect of HBV related hepatitis by nucleotide analogue or HB vaccination.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of HBV reactivation
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Positive for HBsAg or anti-HBc, or anti-HBs
Key exclusion criteria
Drug allergy for entecavir or HB vaccine
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Tamori |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
5458585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka
TEL
06-6645-3811
atamori@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Tamori |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Hepatology
Zip code
5458585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL
06-6645-3811
Homepage URL
atamori@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Hepatology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Hepatology, Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee, Osaka City University Graduate School of Medicine
Address
1-5-7, Asahimachi, Abeno-ku, Osaka
Tel
06-6646-6125
ethics@med.osaka-cu.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
| 2020 | Year | 12 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
198 cohorts have been enrolled to the present study.
Management information
Registered date
| 2012 | Year | 12 | Month | 06 | Day |
Last modified on
| 2022 | Year | 06 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011151
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
