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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | Chronic Hepatitis B patients who pretreated with Entecavir |
|
| Comparator group | Active Comparator | Chronic Hepatitis B patients who pretreated with Entecavir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vemliver tablet | Drug | Chronic Hepatitis B Patients Who Pretreated with Entecavir switching to Vemliver tab (Tenofovir Alafenamide Hemitartrate) |
|
| Measure | Description | Time Frame |
|---|---|---|
| HBV viral suppression rate | HBV viral suppression rate at 48 weeks post-baseline | 48 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| HBV viral suppression rate | HBV viral suppression rate at 24 weeks post-baseline | 24 weeks |
| ALT normalization rate | ALT normalization rate at 24 weeks post-baseline |
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Inclusion Criteria:
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.
Exclusion Criteria:
Medical history or surgical (treatment) history at the time of screening visit:
â‘ 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.
Coexisting conditions at the time of screening visit:
â‘ Non-selective clinical signs/symptoms in non-selective liver disease.
Galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
Laboratory test results at the time of screening visit:
â‘ Co-infection with HCV and HIV.
Hemoglobin <8 g/dL.
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.
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| Name | Affiliation | Role |
|---|---|---|
| Yoon Jun Kim | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42015653 | Derived | 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 Apr 22. doi: 10.5009/gnl250479. Online ahead of print. |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| Baracross Tablet | Drug | Chronic Hepatitis B Patients Who Pretreated with Entecavir continuting treatement with Baracross Tablet |
|
| 24 weeks |
| ALT normalization rate | ALT normalization rate at 48 weeks post-baseline | 48 weeks |
| Change from baseline in ALT | Change from baseline in ALT at 24 weeks post-baseline | 24 weeks |
| Change from baseline in ALT | Change from baseline in ALT at 48 weeks post-baseline | 48 weeks |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |