Hepatitis B, ChronicPhase 4NCT06000657
Efficacy and Safety of Switching to Vemliver From Entecavir in Chronic Hepatitis B Patients Previously Treated With Entecavir
A Phase 4 study testing Vemliver tablet and Baracross Tablet in people with Hepatitis B, Chronic, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV antiviral (HBV DNA <69 IU/mL) effects. Subjects are given one test drug or comparator once a day for 48 weeks according to the results of random assignments, and their HBV antiviral inhibitory effect and safety are evaluated at 24… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hepatitis B, Chronic
- What is being tested?
- Vemliver tablet and Baracross Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Aug 2023to 3 Feb 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged 19 years and older as of the date of written consent.
- Individuals with a positive HBsAg for at least 24 weeks prior to screening or a history of chronic hepatitis B.
- Individuals with chronic hepatitis B who have been receiving ETV 0.5 mg as monotherapy for at least 24 weeks and have expressed the intention to switch to Barakros tablets or Bemeliver tablets.
- Participants with good adherence to ETV 0.5 mg monotherapy confirmed through questionnaire (≥80%).
- Participants who have demonstrated viral suppression efficacy (HBV DNA <69 IU/mL) and are deemed to require monotherapy with Tenofovir alafenamide or ETV for at least 48 weeks.
- Individuals who voluntarily agree to participate in the clinical trial and have signed the informed consent form.
Who cannot join
- Medical history or surgical (treatment) history at the time of screening visit:
- ① Individuals diagnosed with substance abuse or alcohol addiction within the past year of screening.
- Confirmed diagnosis of malignant tumors, including liver cancer, within the past 5 years.
- Organ or bone marrow transplant recipients.
- Coexisting conditions at the time of screening visit:
- ① Non-selective clinical signs/symptoms in non-selective liver disease.
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- Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
- Kidney disease patients requiring hemodialysis or peritoneal dialysis. ④ Other clinically significant cardiovascular, respiratory, neurological, or psychiatric conditions considered inappropriate for participation in the clinical trial according to the participant's judgment.
- Laboratory test results at the time of screening visit:
- ① Co-infection with HCV and HIV.
- Hemoglobin <8 g/dL.
- Impaired renal function. ④ ALT >3 × ULN.
- Anticipated use of the following drugs during the specified period:
- During the clinical trial period:
- Immunosuppressants.
- Systemic corticosteroids administered at a dose equal to or greater than a restricted dose for more than 2 weeks.
- Drugs affecting renal excretion, drugs with renal or hepatic toxicity. ④ Anti-HBV drugs other than investigational medicinal products. ⑤ Hepatotonics.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Switching to Vemliver (Tenofovir Alafenamide) From Entecavir in Chronic Hepatitis B: A Multi-Center, Phase IV, Open-Label, Randomized, Active-Controlled, Non-Inferiority Trial.
Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV antiviral (HBV DNA <69 IU/mL) effects.
Subjects are given one test drug or comparator once a day for 48 weeks according to the results of random assignments, and their HBV antiviral inhibitory effect and safety are evaluated at 24 and 48 weeks visits.
Read the detailed description
Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV antiviral (HBV DNA <69 IU/mL) effects.
At the time of screening, potential test subjects of this test are selected by retrospectively collecting information on disease status and prognosis-related factors, including ETV administration information, among those who voluntarily agreed to participate in this clinical trial.
HBeAg status (positive vs. positive) through Visit 1's Heptatis B Serology test before administering clinical trial drugs to test subjects who finally qualify for selection/exclusion criteria at the baseline. Voice) is set as a stratification factor and is randomly assigned to each test institution.
Subjects are given one test drug or comparator once a day for 48 weeks according to the results of random assignments, and their HBV antiviral inhibitory effect and safety are evaluated at 24 and 48 weeks visits.
- Conditions
- Hepatitis B, Chronic
- Being tested
- Vemliver tablet, Baracross Tablet
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vemliver tabletDrug
Chronic Hepatitis B Patients Who Pretreated with Entecavir switching to Vemliver tab (Tenofovir Alafenamide Hemitartrate)
Baracross TabletDrug
Chronic Hepatitis B Patients Who Pretreated with Entecavir continuting treatement with Baracross Tablet
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Chronic Hepatitis B patients who pretreated with Entecavir Receives: Drug: Vemliver tablet |
| Comparator group | Active comparator | Chronic Hepatitis B patients who pretreated with Entecavir Receives: Drug: Baracross Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV viral suppression rate
HBV viral suppression rate at 48 weeks post-baseline
Measured: 48 weeks
Secondary outcomes (5)
HBV viral suppression rate
HBV viral suppression rate at 24 weeks post-baseline
Measured: 24 weeks
ALT normalization rate
ALT normalization rate at 24 weeks post-baseline
Measured: 24 weeks
ALT normalization rate
ALT normalization rate at 48 weeks post-baseline
Measured: 48 weeks
Change from baseline in ALT
Change from baseline in ALT at 24 weeks post-baseline
Measured: 24 weeks
Change from baseline in ALT
Change from baseline in ALT at 48 weeks post-baseline
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start28 Aug 2023
- Primary completion3 Feb 2025
- Study completion3 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoon Jun Kim, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000657
- Sponsor's protocol ID
- DWVMLV_P401
- Status last verified
- Mar 2025
- First submitted
- 16 Jul 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet decided
Publications
Shin H, Hur MH, Baek YH, Lee CK, Cho YK, Lee JS, Jeong JY, Jung YJ, Kim JK, Kim MY, Seo YS, Chung WJ, Koh MS, Kim JH, Lee YB, Cho EJ, Lee JH, Yu SJ, Yoon JH, Kim YJ. Efficacy and Safety of Switching from Entecavir to Tenofovir Alafenamide in Chronic Hepatitis B: A Multicenter Randomized Trial in Korea. Gut Liver. 2026 Jul 15;20(4):636-644. doi: 10.5009/gnl250479. Epub 2026 Apr 22.
PubMed 42015653
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Switching to Vemliver (Tenofovir Alafenamide) From Entecavir in Chronic Hepatitis B: A Multi-Center, Phase IV, Open-Label, Randomized, Active-Controlled, Non-Inferiority Trial.
- ClinicalTrials.gov ID
- NCT06000657
- Acronym / sponsor ID
- DWVMLV_P401
- Conditions
- Hepatitis B, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 3 Feb 2025 (actual)
- Study completion
- 3 Feb 2025 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV antiviral (HBV DNA <69 IU/mL) effects.
Subjects are given one test drug or comparator once a day for 48 weeks according to the results of random assignments, and their HBV antiviral inhibitory effect and safety are evaluated at 24 and 48 weeks visits.
Detailed description
Enroll patients who are pre-treated with Entecavir at least 24 weeks and confirmed HBV antiviral (HBV DNA <69 IU/mL) effects.
At the time of screening, potential test subjects of this test are selected by retrospectively collecting information on disease status and prognosis-related factors, including ETV administration information, among those who voluntarily agreed to participate in this clinical trial.
HBeAg status (positive vs. positive) through Visit 1's Heptatis B Serology test before administering clinical trial drugs to test subjects who finally qualify for selection/exclusion criteria at the baseline. Voice) is set as a stratification factor and is randomly assigned to each test institution.
Subjects are given one test drug or comparator once a day for 48 weeks according to the results of random assignments, and their HBV antiviral inhibitory effect and safety are evaluated at 24 and 48 weeks visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Vemliver tabletChronic Hepatitis B patients who pretreated with Entecavir |
| Comparator group | Active comparator | Drug: Baracross TabletChronic Hepatitis B patients who pretreated with Entecavir |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants aged 19 years and older as of the date of written consent.
- Individuals with a positive HBsAg for at least 24 weeks prior to screening or a history of chronic hepatitis B.
- Individuals with chronic hepatitis B who have been receiving ETV 0.5 mg as monotherapy for at least 24 weeks and have expressed the intention to switch to Barakros tablets or Bemeliver tablets.
- Participants with good adherence to ETV 0.5 mg monotherapy confirmed through questionnaire (≥80%).
- Participants who have demonstrated viral suppression efficacy (HBV DNA <69 IU/mL) and are deemed to require monotherapy with Tenofovir alafenamide or ETV for at least 48 weeks.
Key exclusion criteria (17 listed)
- ① Individuals diagnosed with substance abuse or alcohol addiction within the past year of screening.
- ① Non-selective clinical signs/symptoms in non-selective liver disease.
- ① Co-infection with HCV and HIV.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vemliver tabletChronic Hepatitis B Patients Who Pretreated with Entecavir switching to Vemliver tab (Tenofovir Alafenamide Hemitartrate) | Drug | Treatment group |
| Baracross TabletChronic Hepatitis B Patients Who Pretreated with Entecavir continuting treatement with Baracross Tablet | Drug | Comparator group |
Primary outcome
HBV viral suppression rate
Time frame: 48 weeks
HBV viral suppression rate at 48 weeks post-baseline
5 secondary outcomes
HBV viral suppression rate
Time frame: 24 weeks
ALT normalization rate
Time frame: 24 weeks
ALT normalization rate
Time frame: 48 weeks
Change from baseline in ALT
Time frame: 24 weeks
Change from baseline in ALT
Time frame: 48 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Derived from this study: PubMed 42015653Shin H, Hur MH, Baek YH, Lee CK, Cho YK, Lee JS, Jeong JY, Jung YJ, Kim JK, Kim MY, Seo YS, Chung WJ, Koh MS, Kim JH, Lee YB, Cho EJ, Lee JH, Yu SJ, Yoon JH, Kim YJ. Efficacy and Safety of Switching from Entecavir to Tenofovir Alafenamide in Chronic Hepatitis B: A Multicenter Randomized Trial in Korea. Gut Liver. 2026 Jul 15;20(4):636-644. doi: 10.5009/gnl250479. Epub 2026 Apr 22.
- Individual participant dataSharing planned: Undecided. Not yet decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon Jun Kim principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vemliver tablet and Baracross Tablet in people with Hepatitis B, Chronic, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBV viral suppression rate (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06000657, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025; AzTrials last refreshed its copy on 8 Nov 2026.