UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053257 |
|---|---|
| Receipt number | R000060779 |
| Scientific Title | Discontinuation Criteria for Nucleic Acid Analogues Administered for the Prevention of Hepatitis B Virus Reactivation |
| Date of disclosure of the study information | 2024/01/04 |
| Last modified on | 2024/01/13 23:24:50 |
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Basic information
Public title
Discontinuation Criteria for Nucleic Acid Analogues Administered for the Prevention of Hepatitis B Virus Reactivation
Acronym
Discontinuation Criteria for Nucleic Acid Analogues Administered for the Prevention of HBV Reactivation
Scientific Title
Discontinuation Criteria for Nucleic Acid Analogues Administered for the Prevention of Hepatitis B Virus Reactivation
Scientific Title:Acronym
Discontinuation Criteria for Nucleic Acid Analogues Administered for the Prevention of HBV Reactivation
Region
| Japan |
Condition
Condition
Hepatitis B virus reactivation
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Criteria for discontinuation of nucleic acid analogues (NA) administered for prevention of hepatitis B virus (HBV) reactivation are controversial. In a previous multicenter retrospective study, we showed that discontinuation of NA administered for HBV reactivation prophylaxis can be considered in patients with the following two conditions: (1) non-hematologic disease background and primary disease in remission and (2) NA administered for HBV reactivation prophylaxis for at least 12 months. The purpose of this study is to prospectively evaluate whether the above criteria for discontinuation of NA for prevention of HBV reactivation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients who required reintroduction of NA after discontinuation of NA administered for prevention of HBV reactivation.
Key secondary outcomes
Changes in HBV DNA, HBs antigen, and ALT after discontinuation of NA, and the presence of adverse events such as hepatitis.
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Discontinue NA administered for prevention of HBV reactivation in patients who have consented to clinical research in candidates from the following selection of research subjects.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who have undergone remission after anticancer therapy for solid tumors
2)Patients who have taken NA for more than 12 months to prevent reactivation of HBV.
3)Patients who started NA between January 2000 and March 2027
4)Patients who are 18 years of age or older at the time of initiation of NA administration
5)Patients who have obtained consent from the patient or the patient's surrogate
Key exclusion criteria
1)Patients who do not meet any of the selection criteria
2)Patients with hematological diseases
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kentaro |
| Middle name | |
| Last name | Matsuura |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
Kawasumi, Mizuho, Nagoya, Aichi, Japan.
TEL
052-853-8211
matsuura@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takanori |
| Middle name | |
| Last name | Suzuki |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Department of Gastroenterology and Metabolism
Zip code
467-8601
Address
Kawasumi, Mizuho, Nagoya, Aichi, Japan.
TEL
052-853-8211
Homepage URL
takanorii.suzukii@gmail.com
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Not applicable
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Nagoya City University Medical Research
Address
Kawasumi, Mizuho, Nagoya, Aichi, Japan.
Tel
052-858-7215
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 04 | 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
| 2023 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 09 | Day |
Last follow-up date
| 2028 | 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
| 2024 | Year | 01 | Month | 02 | Day |
Last modified on
| 2024 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060779
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