UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062030 |
|---|---|
| Receipt number | R000070981 |
| Scientific Title | Prediction and Assessment of Hepatitis B Virus Reactivation Risk Under Immunosuppressive Therapy |
| Date of disclosure of the study information | 2026/06/23 |
| Last modified on | 2026/06/23 17:24:17 |
* 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
Prediction and Assessment of Hepatitis B Virus Reactivation Risk Under Immunosuppressive Therapy
Acronym
Prediction and Assessment of Hepatitis B Virus Reactivation Risk Under Immunosuppressive Therapy
Scientific Title
Prediction and Assessment of Hepatitis B Virus Reactivation Risk Under Immunosuppressive Therapy
Scientific Title:Acronym
HBV Reactivation Risk Prediction Study
Region
| Japan |
Condition
Condition
HBV reactivation
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to develop an artificial intelligence (AI)-based predictive model capable of distinguishing progression to true HBV reactivation from spontaneous viral clearance by training on longitudinal viral load trajectories and clinical outcomes of patients with HBV reactivation who did not receive antiviral therapy. This multicenter study will be conducted in collaboration with 18 institutions across Japan, including Kyoto University Hospital. The proposed model is expected to enable evidence-based decision-making regarding individualized monitoring strategies and the optimal timing of therapeutic intervention. Ultimately, this approach may help avoid unnecessary antiviral treatment while contributing to the prevention of severe hepatitis associated with HBV reactivation.
Basic objectives2
Others
Basic objectives -Others
-To characterize longitudinal patterns of HBV DNA kinetics in patients with HBV reactivation.
-To identify clinical and virological factors associated with progression to clinically significant HBV reactivation (HBV DNA levels above 3.3 log IU/mL).
-To classify HBV DNA trajectory patterns using a Latent Class Mixed Model and evaluate the association between each cluster and subsequent clinical outcomes.
-To assess the discriminatory performance and predictive accuracy of the developed AI-based prediction model in an independent validation cohort.
-To evaluate the validity of model-guided monitoring intervals and criteria for initiation of antiviral therapy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Progression to clinically significant HBV reactivation (HBV DNA >3.3 log IU/mL)
Key secondary outcomes
the rate of spontaneous viral clearance, longitudinal changes in HBV DNA levels, the incidence of hepatitis accompanied by ALT elevation, the initiation and timing of nucleos(t)ide analogue therapy, and the discriminatory performance and diagnostic accuracy of the developed prediction model
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
| 94 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with resolved HBV infection, defined as HBsAg-negative and anti-HBc and/or anti-HBs-positive, who showed seroconversion of serum HBV DNA from below the detection or quantification limit and were diagnosed with HBV reactivation.
Key exclusion criteria
Cases of HBV infection/reactivation considered to be derived from the graft liver after living donor liver transplantation will be excluded.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Inuzuka |
Organization
Kyoto University, Graduate School of Medicine
Division name
Department of Community Medicine
Zip code
6068507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757514319
tinuzuka@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Inuzuka |
Organization
Kyoto University, Graduate School of Medicine
Division name
Gastroenterology and Hepatology Department
Zip code
6068507
Address
54 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
TEL
0757514319
Homepage URL
tinuzuka@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Tadashi Inuzuka
Funding Source
Organization
Kyoto University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin Kawahara-cho, Sakyo-ku, Kyoto
Tel
0753667618
ethcom@kuhp.kyoto-u.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
| 2026 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 06 | Month | 23 | 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
This study is a multicenter retrospective observational study. Patients diagnosed with HBV reactivation between January 1, 2009 and June 30, 2025 at Kyoto University Hospital and collaborating institutions will be included. Existing clinical data obtained from medical records and laboratory databases will be analyzed to evaluate longitudinal HBV DNA kinetics, clinical characteristics, treatment interventions, and clinical outcomes. The association between HBV DNA dynamics and subsequent outcomes in patients who did not receive antiviral therapy will be investigated, and an AI-based model will be developed and validated to predict progression to clinically significant HBV reactivation or spontaneous viral clearance.
Management information
Registered date
| 2026 | Year | 06 | Month | 23 | Day |
Last modified on
| 2026 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070981
