UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046803 |
|---|---|
| Receipt number | R000053403 |
| Scientific Title | Retrospective analysis of cases with HBV reactivation after Hematopoietic Stem Cell Transplantation |
| Date of disclosure of the study information | 2022/02/03 |
| Last modified on | 2024/02/04 21:38:01 |
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Basic information
Public title
Retrospective analysis of cases with HBV reactivation after Hematopoietic Stem Cell Transplantation
Acronym
HBV reset
Scientific Title
Retrospective analysis of cases with HBV reactivation after Hematopoietic Stem Cell Transplantation
Scientific Title:Acronym
HBV reset
Region
| Japan |
Condition
Condition
HBV reactivation after hematopoietic cell transplantation
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
analysis of case with HBV reactivation after hematopoietic cell transplantation
Basic objectives2
Others
Basic objectives -Others
analysis of re-reactivation of HBV after cessation of nucleotide analogue
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
re-reactivation of HBV after cessation of nucleotide analogue
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) A patient who developed HBV reactivation after HSCT and treated by nucleotide analogue during the period from 2010 Jun to 2020 Dec.
2) any hematological disorder, any number of times of HCT, any stem cell donor source
3) A patient undergone HCT at age 20 or more
Key exclusion criteria
1) A patient who was confirmed HBs antigen positive before HCT
2) A patient treat by nucleotide analogue before the diagnosis of HBV reactivation
3) A patient who refuses entry to the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Onozawa |
Organization
Hokkaido University Hospital
Division name
Department of Hematology
Zip code
060-8648
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
TEL
011-716-1161
onozawa@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Onozawa |
Organization
Hokkaido University Hospital
Division name
Department of Hematology
Zip code
060-8648
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
TEL
011-716-1161
Homepage URL
onozawa@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-ku, Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
北海道大学病院(北海道)
札幌北楡病院(北海道)
市立函館病院(北海道)
市立旭川病院(北海道)
岩手医科大学附属病院(岩手県)
東北大学病院(宮城県)
独立行政法人国立病院機構仙台医療センター(宮城県)
山形大学医学部附属病院(山形県)
自治医科大学附属病院(栃木県)
埼玉医科大学総合医療センター(埼玉県)
自治医科大学附属さいたま医療センター(埼玉県)
埼玉県立がんセンター(埼玉県)
成田赤十字病院(千葉県)
都立駒込病院(東京都)
慶應義塾大学病院(東京都)
東京医科歯科大学病院(東京都)
日本医科大学付属病院(東京都)
神奈川県立がんセンター(神奈川県)
横浜市立大学附属市民総合医療センター(神奈川県)
金沢大学附属病院(金沢県)
長野赤十字病院(長野県)
岐阜大学医学部附属病院(岐阜県)
岐阜市民病院(岐阜県)
浜松医科大学附属病院(静岡県)
名古屋第一赤十字病院(愛知県)
名古屋大学医学部附属病院(愛知県)
国立病院機構名古屋医療センター(愛知県)
名古屋市立大学病院(愛知県)
安城更生病院(愛知県)
江南厚生病院(愛知県)
京都大学医学部附属病院(京都府)
大阪国際がんセンター(大阪府)
近畿大学医学部附属病院(大阪府)
兵庫県立がんセンター(兵庫県)
神戸市立医療センター中央市民病院(兵庫県)
神戸大学医学部附属病院(兵庫県)
兵庫県立尼崎総合医療センター(兵庫県)
近畿大学医学部奈良病院(奈良県)
和歌山県立医科大学(和歌山県)
島根大学医学部附属病院(島根県)
倉敷中央病院(岡山県)
岡山大学病院(岡山県)
広島赤十字・原爆病院(広島県)
広島大学(広島県)
徳島大学病院(徳島県)
高知医療センター(高知県)
原三信病院(福岡県)
久留米大学(福岡県)
国立病院機構九州がんセンター(福岡県)
JCHO 九州病院(福岡県)
佐賀大学医学部附属病院(佐賀県)
長崎大学病院(長崎県)
佐世保市総合医療センター(長崎県)
熊本大学病院(熊本県)
熊本医療センター(熊本県)
大分大学医学部附属病院(大分県)
宮崎大学医学部附属病院(宮崎県)
今村総合病院(鹿児島県)
鹿児島大学病院(鹿児島県)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/38242442/
Number of participants that the trial has enrolled
72
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 01 | Month | 17 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 01 | Month | 28 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective questioner
Management information
Registered date
| 2022 | Year | 02 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053403
