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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034113
Receipt No. R000037921
Scientific Title Prophylaxis of HBV reactivation by vaccination enforcing post-transplant HBV immunity
Date of disclosure of the study information 2018/09/24
Last modified on 2019/09/14

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Basic information
Public title Prophylaxis of HBV reactivation by vaccination enforcing post-transplant HBV immunity
Acronym PREVENT HBV
Scientific Title Prophylaxis of HBV reactivation by vaccination enforcing post-transplant HBV immunity
Scientific Title:Acronym PREVENT HBV
Region
Japan

Condition
Condition HSCT recipient with resolved infection of HBV
Classification by specialty
Hematology and clinical oncology Infectious disease
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Prospective Randomized trial to show efficacy of post-HSCT HB vaccination against HBV reactivation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HBV reactivation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Vaccine
Interventions/Control_1 HB vaccine arm
HBV DNA and anti-HBs antibody are monitored every 28 days, and preemptive nucleoside analogue is administered when reactivation of HBV is observed.
Inoculations of HB vaccine are planed on day 196, day 224, and day 364 after HSCT.
If the titer of anti-HBs antibody is less than 10 mIU/mL on day392, additional vaccines are planed on day 420, day 448, and day 588 after HSCT.
Interventions/Control_2 non-HB vaccine arm
HBV DNA and anti-HBs antibody are monitored every 28 days, and preemptive nucleoside analogue is administered when reactivation of HBV is observed.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria (1) Patient is planed to undergo 1st hematopoietic stem cell transplantation
(2) HBs antigen negative and anti-HBc antibody positive
(3) more than 20 year-old and less than 70 year-old
(4) Those patient who give written informed consent
Key exclusion criteria (1) anti-HCV antibody negative
(2) anti-HIV antibody negative
(3) HBV DNA>=1.3 Log IU/mL
(4) anti-HBc antibody negative
(5) seroconversion of anti-HBc antibody negative to positive after infusion of blood product
(6) previous HBV reactivation
(7) previous history of treatment using nucleoside analogue, or plan to prescribe nucleoside analogue for prophylaxis
(8) anaphylaxis for previous vaccine
(9) conditioning regimen has been started for first HSCT
(10) complication of severe infection
(11) hemodialysis has been started or planed to be induced
(12) uncontrollable diabetics, hypertension or heart failure
(13) woman during pregnant or lactation
(14) patient who plan to move or plan to be followed by other institute during 2-year after HSCT
(15) patient who is not been considered to be eligible to the study by a doctor in charge by miscellaneous reasons
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Masashi
Middle name
Last name Mizokami
Organization National Center for Global Health and Medicine
Division name Genome Medical Science Project
Zip code 272-8516
Address 1-7-1, Konodai, Ichikawa, Chiba
TEL 047-372-3501
Email mmizokami@hospk.ncgm.go.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, Hokkaido
TEL 011-706-7214
Homepage URL
Email onozawa@med.hokudai.ac.jp

Sponsor
Institute National Center for Global Health and Medicine
Genome Medical Science Project
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor The Japanese Data Center for Hematolopoietic Cell Transplantation
SRL
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagoya City University Hospital, Clinical Research Management Center
Address Aza-kawasumi1, Mizuhocho, Mizuho-ku, Nagoya, Aichi
Tel 052-858-7215
Email clinical_research@med.nagoya-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 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)
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)
都立駒込病院(東京都)
慶應義塾大学病院(東京都)
日本医科大学付属病院(東京都)
東京都健康長寿医療センター(東京都)
神奈川県立がんセンター(神奈川県)
新潟大学医歯学総合病院(新潟県)
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(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)
JCHO京都鞍馬口医療センター(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(大阪府)
大阪市立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)
神戸大学医学附属病院(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)
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)
広島大学病院(広島県)
徳島大学病院(徳島県)
九州大学病院(福岡県)
原三信病院 (福岡県)
久留米大学病院(福岡県)
九州医療センター(福岡県)
JCHO九州病院(福岡県)
長崎大学病院(長崎県)
佐世保市総合医療センター(長崎県)
熊本医療センター(熊本県)
大分大学医学部附属病院(大分県)
大分県立病院(大分県)
今村総合病院(鹿児島県)

Other administrative information
Date of disclosure of the study information
2018 Year 09 Month 24 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
2018 Year 07 Month 14 Day
Date of IRB
2018 Year 09 Month 13 Day
Anticipated trial start date
2018 Year 09 Month 24 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 09 Month 13 Day
Last modified on
2019 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037921

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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