Efficacy and Safety of Switching to Vemliver From Entecavir in Chronic Hepatitis B Patients Previously Treated With Entecavir

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.

Study Overview

• Status: Completed
• Conditions: Hepatitis B, Chronic
• Intervention / Treatment: Drug: Vemliver tablet; Drug: Baracross Tablet

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 Type: Interventional
• Enrollment (Actual): 196
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Participants aged 19 years and older as of the date of written consent.
2. Individuals with a positive HBsAg for at least 24 weeks prior to screening or a history of chronic hepatitis B.
3. 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.
4. Participants with good adherence to ETV 0.5 mg monotherapy confirmed through questionnaire (≥80%).
5. 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.

6. 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:

   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.

   • 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Chronic Hepatitis B patients who pretreated with Entecavir	Drug: Vemliver tablet; Chronic Hepatitis B Patients Who Pretreated with Entecavir switching to Vemliver tab (Tenofovir Alafenamide Hemitartrate)
Active Comparator: Comparator group; Chronic Hepatitis B patients who pretreated with Entecavir	Drug: Baracross Tablet; Chronic Hepatitis B Patients Who Pretreated with Entecavir continuting treatement with Baracross Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBV viral suppression rate	HBV viral suppression rate at 48 weeks post-baseline	48 weeks

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Yoon Jun Kim, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2023
• Primary Completion (Actual): February 3, 2025
• Study Completion (Actual): February 3, 2025

Study Registration Dates

• First Submitted: July 16, 2023
• First Submitted That Met QC Criteria: August 17, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Blood-Borne Infections; Pathologic Processes; Chronic Disease; Disease Attributes; Infections; RNA Virus Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis, Chronic; Hepatitis A; Hepatitis; Hepatitis B; Hepatitis B, Chronic; Anti-Infective Agents; Antiviral Agents; Entecavir
• Other Study ID Numbers: DWVMLV_P401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not yet decided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No