UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020029 |
|---|---|
| Receipt number | R000023107 |
| Scientific Title | The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection |
| Date of disclosure of the study information | 2015/12/01 |
| Last modified on | 2023/12/25 23:33:35 |
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Basic information
Public title
The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection
Acronym
Monitoring by HBs antigen for HBV Reactivation
Scientific Title
The significance of serum HBs-antigen as a monitoring examination for viral reactivation during immunesuppressive therapy in patients with previously resolved hepatitis B virus infection
Scientific Title:Acronym
Monitoring by HBs antigen for HBV Reactivation
Region
| Japan |
Condition
Condition
Collagen disease, collagen disease related disease, ulcerative colitis, Crohn's disease, intestinal Behcet's disease (simple ulcers included), psoriasis, and diseases that require other immunosuppressive therapies.
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Clinical immunology |
| Dermatology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the significance of HBs-antigen as a monitoring examination for HBV reactivation in patients with previously resolved HBV infection, serum levels of HBs-antigen as well as HBV-DNA are measured repeatedly during immunosuppressive therapies, and entecavir administration is done when serum HBV-DNA levels increase up to 3 Log IU/mL and/or serum HBs-antigen becomes detectable.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Both serum HBs-antigen and HBV-DNA are monitored repeatedly every 1 to 3 months during immunosuppressive therapies, and development of de novo HBV hepatitis is evaluated until 12 months after initiation of the therapies.
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
| Medicine |
Interventions/Control_1
Entecavir administration is initiated when serum HBV-DNA levels increased up to 3.0 Log/IU/mL, and/or serum HBs-antigen becomes detectable and serum HBV-DNA levels is 2.0 Log/IU/mL or more.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients tested positive for serum anti-HBs and/or anti-HBc despite of a negative serum HBs-antigen status
Key exclusion criteria
Patients tested positive for serum HBs-antigen
Patients receiving an HBs-antigen vaccination
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Mochida |
Organization
Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
350-0495
Address
Morohongo 38, Moroyama-Machi, Iruma-Gun, Saitama, 350-0495, Japan
TEL
049-276-1198
smochida@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Nobuaki |
| Middle name | |
| Last name | Nakayama |
Organization
Saitama Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
350-0495
Address
Morohongo 38, Moroyama-Machi, Iruma-Gun, Saitama, 350-0495, Japan
TEL
049-276-1198
Homepage URL
kgoto@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, Saitama Medical University
Address
orohongo 38, Moroyama-Machi, Iruma-Gun, Saitama, 350-0495, Japan
Tel
049-276-1354
hirb@saitama-med.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 01 | 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
22
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | 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
Management information
Registered date
| 2015 | Year | 12 | Month | 01 | Day |
Last modified on
| 2023 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023107
| 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 |
