UMIN-CTR Clinical Trial

Basic information
Public title	A prospective, multiple center trial for incidence and prevention of hepatitis B virus (HBV) reactivation following hematopoietic stem cell transplantation (HSCT)
Acronym	A trial for HBV reactivation in HSCT recipients.
Scientific Title	A prospective, multiple center trial for incidence and prevention of hepatitis B virus (HBV) reactivation following hematopoietic stem cell transplantation (HSCT)
Scientific Title:Acronym	A trial for HBV reactivation in HSCT recipients.
Region	Japan

Condition
Condition	Patients with resolved HBV infection who receive hematopoietic stem cell transplantation
Classification by specialty	Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To determine preventive effect of HB vaccination against reactivation in HSCT recipients with resolved HBV infection (HBsAg(-), HBcAb(+)), we conducted prospective study. Frequency of HBV reactivation after HSCT and efficacy of HBV-DNA monitoring will be assessed.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Frequency of HBV reactivation in HSCT recipients immunized with HB vaccination.
Key secondary outcomes

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	HB vaccination
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	75 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients who will undergo first HSCT 2. Patients with HBs antigen negative and HBc antibody positive 3. Patients with serum total bilirubin <=2.0mg/dl 4. Patients with serum AST and ALT <= 2.5 x ULN 5. Patients with serum creatinine <= 1.5 xULN 6. Patients with PaO2 >=60Torr on room air or SpO2 >=90% 7.Patients with performance status 0,1 or 2 8. Patients who are 20 to 75 years old 9. Patients who gave consent for this trial
Key exclusion criteria	1. Patients with HCV antibody positive 2. Patients with HIV antibody positive 3. Patients who are allergic to vaccination 4. Patients who are allergic to biologics 5. Patients with severe infectious disease (Patients whose general condition seemed to be poor like as septic shock ) 6. Patient who undergo hemodialysis 7. Patients with mental disorder which is object of treatment 8. Patients with poorly controlled DM, HT, or heart failure 9. Patients who are pregnant or nursing 10. Patients who are judged ineligible for this trial
Target sample size	66

Research contact person
Name of lead principal investigator	1st name Kiminori Middle name Last name Kimura
Organization	Tokyo Metropolitan Komagome Hospital
Division name	Division of Hepatology
Zip code	113-8677
Address	3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL	03-3823-2101
Email	kiminori_kimura@tmhp.jp

Public contact
Name of contact person	1st name Kiminori Middle name Last name Kimura
Organization	Tokyo Metropolitan Komagome Hospital
Division name	Division of Hepatology
Zip code	113-8677
Address	3-18-22, Honkomagome, Bunkyo-ku, Tokyo
TEL	03-3823-2101
Homepage URL
Email	kiminori_kimura@tmhp.jp

Sponsor
Institute	Kiminori Kimura
Institute
Department

Funding Source
Organization	Health labor science research grant
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Komagome Hospital Institutional Review Board
Address	3-18-22, Honkomagome, Bunkyo-ku, Tokyo, Japan
Tel	0338232101
Email	km_koma_chiken@tmhp.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	・東京都立駒込病院（東京都） ・東京都立多摩総合医療センター(東京都） ・自治医科大学附属さいたま医療センター（埼玉県） ・東京医科歯科大学（東京都） ・北海道大学医学部（北海道） ・東北大学病院（宮城県） ・国家公務員共済組合連合会　浜の町病院（福岡県） ・兵庫県立がんセンター（兵庫県） ・東海大学医学部（神奈川県） ・久留米大学医学部（福岡県） ・自治医科大学附属病院(栃木県)

Other administrative information
Date of disclosure of the study information	2013 Year 08 Month 23 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	2013 Year 08 Month 16 Day
Date of IRB	2013 Year 08 Month 16 Day
Anticipated trial start date	2013 Year 09 Month 01 Day
Last follow-up date	2019 Year 01 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 08 Month 21 Day
Last modified on	2022 Year 07 Month 08 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013499