UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021793 |
|---|---|
| Receipt number | R000021278 |
| Scientific Title | Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2026/04/14 10:25:09 |
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Basic information
Public title
Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial
Acronym
Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial
Scientific Title
Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial
Scientific Title:Acronym
Efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in chronic hepatitis B: a randomized controlled trial
Region
| Japan |
Condition
Condition
chronic hepatitis B
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of entecavir-to-tenofovir switching treatment to attain a drug-free state in patients with chronic hepatitis B who underwent entecavir treatment for a long term
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decrease in serum HBsAg level on week 240
Key secondary outcomes
Proportion of viral breakthrough until week 240
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group 1: Continue entecavir
Interventions/Control_2
Group 2: Switch to tenofovir
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. treated with Entecavir for 5 years or longer
2. HBV-DNA<2.1 log copies/mL
3. HBsAg-positive
Key exclusion criteria
1. no previous use of other nucleoside analog
2. presence of resistance to nucleoside analog
3. other likely causes of chronic liver disease, such as autoimmune or alcoholic liver disease
4. viable HCC or other malignancies
5. decompensated liver function (Child B or C)
6. severe complication (ex. impaired renal, cardiac or respiratory function)
7. women who are possibly pregnant, expectant mothers, and lactating mothers
8. history of allergy to nucleoside analog
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Masaru |
| Middle name | |
| Last name | Enomoto |
Organization
Osaka Metropolitan University
Division name
Department of Hepatology
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3905
enomoto-m@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Masaru |
| Middle name | |
| Last name | Enomoto |
Organization
Osaka Metropolitan University
Division name
Department of Hepatology
Zip code
545-8585
Address
1-4-3 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
TEL
06-6645-3905
Homepage URL
enomoto-m@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Hepatology, Osaka Metropolitan University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka Metropolitan University IRB
Address
1-5-7 Asahimachi, Abeno-ku, Osaka 545-8585, Japan
Tel
06-6645-2711
ishomu@med.osaka-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
| 2020 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
10.1002/jmv.25442
Publication of results
Partially published
Result
URL related to results and publications
10.1002/jmv.25442
Number of participants that the trial has enrolled
27
Results
iMean decreases in HBsAg level at week 48 were 0.023 and 0.042 log10 IU/mL in the TDF and ETV groups, respectively (P = 0.94). The mean drops in hepatitis B core-related antigens were also not different between the TDF and ETV groups at week 48 (P = 0.80). HBV DNA was sustainedly <2.1 log 10 copies/mL in all patients throughout the study period. In contrast, the mean aminotransferase levels were significantly higher in the TDF group than in the ETV group at weeks 12, 24, and 36.
Results date posted
| 2026 | Year | 04 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Twenty-seven nucleos(t)ide-naive patients with chronic HBV who underwent ETV therapy for 5 years and maintained virological response were included.
Participant flow
The 27 nucleos(t)ide-naive patients were included and randomized into two groups: one group continued ETV, and the other switched to TDF, in a 1:2 ratio.
Adverse events
None
Outcome measures
The primary endpoint was changed from baseline in serum hepatitis B surface antigen (HBsAg) level at week 48.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 07 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 07 | Month | 15 | Day |
Last follow-up date
| 2023 | 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
| 2016 | Year | 04 | Month | 06 | Day |
Last modified on
| 2026 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021278
