UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011543 |
|---|---|
| Receipt number | R000013499 |
| Scientific Title | A prospective, multiple center trial for incidence and prevention of hepatitis B virus (HBV) reactivation following hematopoietic stem cell transplantation (HSCT) |
| Date of disclosure of the study information | 2013/08/23 |
| Last modified on | 2022/07/08 13:37:53 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
kiminori_kimura@tmhp.jp
Sponsor or person
Institute
Kiminori Kimura
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013499
