UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059333 |
|---|---|
| Receipt number | R000066571 |
| Scientific Title | A study on the clinical course of chronic hepatitis B under nucleos(t)ide analogue therapy |
| Date of disclosure of the study information | 2025/10/08 |
| Last modified on | 2025/10/08 12:37:46 |
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Basic information
Public title
A study on the clinical course of chronic hepatitis B under nucleos(t)ide analogue therapy
Acronym
A study on the clinical course of chronic hepatitis B under nucleos(t)ide analogue therapy
Scientific Title
A study on the clinical course of chronic hepatitis B under nucleos(t)ide analogue therapy
Scientific Title:Acronym
A study on the clinical course of chronic hepatitis B under nucleos(t)ide analogue therapy
Region
| Japan |
Condition
Condition
Chronic hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the longitudinal changes in HBV related markers among patients with chronic hepatitis B both those receiving nucleos(t)ide analogue (NA) therapy and those not receiving such treatment. Furthermore, to elucidate the clinical outcomes of these patients, including hepatocarcinogenesis, hepatic decompensation events, and death, as well as the factors associated with these outcomes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of HBV-DNA negativity and associated factors
Rate of HBs antigen decline, HBs antigen loss, and associated factors
Rate of HBe antigen seroconversion (in HBeAg-positive cases) and associated factors
Rate of HB core-related antigen decline and associated factors
Rate of ALT normalization and associated factors
Rate of initiation of nucleos(t)ide analogue therapy among untreated cases and associated factors
Rate of transition from the gray zone to the immune-active phase and associated factors
Cumulative incidence of hepatocellular carcinoma and associated factors
Cumulative incidence of hepatic decompensation events and associated factors
Cumulative rate of esophagogastric variceal aggravation and associated factors
Rates of improvement or non-improvement in hepatic fibrosis and hepatic functional reserve, and associated factors
Survival rate and associated factors
Key secondary outcomes
Safety
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with chronic hepatitis B who visited the participating institution after the date of approval by the head of the institution and who are either receiving nucleos(t)ide analogue (NA) therapy or not receiving NA therapy
Individuals aged 18 years or older at the time of obtaining informed consent
Individuals who have continued NA therapy for at least one year (NA treatment group)
Individuals who have provided written informed consent to participate in the study
Key exclusion criteria
Patients co-infected with HCV or HIV
Patients with concomitant hepatocellular carcinoma (HCC)
Patients within 3 months after treatment for HCC
Patients receiving nucleos(t)ide analogues for the prevention of HBV reactivation
Pregnant or lactating women
Individuals deemed ineligible by the principal investigator or co-investigators for any other reason
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Hayato |
| Middle name | |
| Last name | Hikita |
Organization
The Universtiy of Osaka, Graduated School of Medicine
Division name
Department of Gastroneterology and Hepatology
Zip code
5650871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
0668793621
hikita@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Tahata |
Organization
The University of Osaka Graduated School of Medicine
Division name
Department of Gastroneterology and Hepatology
Zip code
5650871
Address
2-2, Yamadaoka, Suita, Osaka
TEL
0668793621
Homepage URL
yuki.tahata@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
None
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
Osaka Univercity Clinical Research Review Committee
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
| 2025 | Year | 10 | Month | 08 | 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
| 2025 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 26 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066571
