UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058105 |
|---|---|
| Receipt number | R000066409 |
| Scientific Title | Evaluation of the Effect of Nucleos(t)ide Analogue Withdrawal for HBs Antigen Clearance as a Functional Cure for Hepatitis B |
| Date of disclosure of the study information | 2025/06/06 |
| Last modified on | 2025/06/06 14:28:46 |
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Basic information
Public title
Evaluation of the Effect of Nucleos(t)ide Analogue Withdrawal for HBs Antigen Clearance as a Functional Cure for Hepatitis B
Acronym
Evaluation of the Effect of Nucleos(t)ide Analogue Withdrawal for HBs Antigen Clearance as a Functional Cure for Hepatitis B
Scientific Title
Evaluation of the Effect of Nucleos(t)ide Analogue Withdrawal for HBs Antigen Clearance as a Functional Cure for Hepatitis B
Scientific Title:Acronym
Evaluation of the Effect of Nucleos(t)ide Analogue Withdrawal for HBs Antigen Clearance as a Functional Cure for Hepatitis B
Region
| Japan |
Condition
Condition
Chronic Hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the Potential for Serum HBs Antigen Clearance Following Discontinuation of Nucleos(t)ide Analog (NA) Therapy for Chronic Hepatitis B
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Proportion of Serum HBs Antigen Clearance Over Four Years After Nucleos(t)ide Analog Discontinuation for Hepatitis B
Key secondary outcomes
Identification of Factors Associated with Response Rate, Efficacy, and Safety
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Discontinuation of Nucleos(t)ide Analog (NA) Therapy for Chronic Hepatitis B
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 HBe antigen-negative hepatitis B receiving NA therapy, in whom serum HBV DNA remains <1.0 Log IU/mL for more than 3 months, and who additionally meet the criteria of HBs antigen <800 IU/mL and HBcr antigen <4.0 Log/mL.
Key exclusion criteria
Patients with liver cirrhosis classified as Child-Pugh B or C.
Patients with concomitant hepatocellular carcinoma.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Tsunamasa |
| Middle name | |
| Last name | Watanabe |
Organization
St.Marianna University School of Medicine
Division name
Department of Gastroenterology
Zip code
216-8511
Address
Kanagawa, Kawasaki 216-8511, Japan
TEL
044-977-8111
twatanab@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Tsunamasa |
| Middle name | |
| Last name | Watanabe |
Organization
St.Marianna University School of Medicine
Division name
Department of Gastroenterology
Zip code
216-8511
Address
Kanagawa, Kawasaki 216-8511, Japan
TEL
044-977-8111
Homepage URL
twatanab@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St. Marianna University School of Medicine Ethics Committee
Address
Kanagawa, Kawasaki 216-8511, Japan
Tel
044-977-8111
twatanab@marianna-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 | 06 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2035 | Year | 12 | 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
| 2025 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066409
