UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018720 |
|---|---|
| Receipt number | R000021653 |
| Scientific Title | Hepatitis B virus reactivation after allogeneic hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2015/08/19 |
| Last modified on | 2015/08/19 11:23:11 |
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Basic information
Public title
Hepatitis B virus reactivation after allogeneic hematopoietic stem cell transplantation
Acronym
HBV reactivation after allogeneic HSCT
Scientific Title
Hepatitis B virus reactivation after allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym
HBV reactivation after allogeneic HSCT
Region
| Japan |
Condition
Condition
Patients with resolved HBV infection who underwent HSCT
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We assess the precipitating factors and timing of HBV reactivation after HSCT in patients with resolved HBV .
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of HBV reactivation after HSCT.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who underwent HSCT
2. Patients with HBs antigen negative, and HBc antibody and/or HBs 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 HIV antibody positive
2. Patients with severe infectious disease (Patients whose general condition seemed to be poor like as septic shock )
3. Patient who undergo hemodialysis
4. Patients with mental disorder which is object of treatment
5. Patients with poorly controlled DM, HT, or heart failure
6. Patients who are pregnant or nursing
7. Patients who are judged ineligible for this trial
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Takahashi |
Organization
Federation of National Public Service Personnel Mutual Aid Associations
Hamanomachi Hospital
Division name
The Center for Liver Disease
Zip code
Address
3-3-1 Nagahama Chuo-ku Fukuoka Japan 810-8539
TEL
092-721-0831
takahashi-k@hamanomachi.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sung Kwan Bae |
Organization
Federation of National Public Service Personnel Mutual Aid Associations Hamanomachi Hospital
Division name
The Center for Liver Disease
Zip code
Address
3-3-1 Nagahama Chuo-ku Fukuoka Japan 810-8539
TEL
092-721-0831
Homepage URL
hai-n@hamanomachi.jp
Sponsor or person
Institute
The center for Liver Disease, Federation of National Public Service Personnel Mutual Aid Associations Hamanomachi Hospital
Institute
Department
Personal name
Funding Source
Organization
The center for Liver Disease, Federation of National Public Service Personnel Mutual Aid Associations Hamanomachi Hospital
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
Address
Tel
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
| 2015 | Year | 08 | Month | 19 | 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
| 2015 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study in a single center
Management information
Registered date
| 2015 | Year | 08 | Month | 19 | Day |
Last modified on
| 2015 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021653
| 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 |
