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

NCT06000657 | Completed Phase 4

• 1 other identifier: DWVMLV_P401
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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 and 48 weeks visits.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (1)

• HBV viral suppression rate

  HBV viral suppression rate at 48 weeks post-baseline

  48 weeks

Secondary Outcomes (5)

• HBV viral suppression rate

  24 weeks

• ALT normalization rate

  24 weeks

• ALT normalization rate

  48 weeks

• Change from baseline in ALT

  24 weeks

• Change from baseline in ALT

  48 weeks

Study Arms (2)

Treatment group

EXPERIMENTAL

Chronic Hepatitis B patients who pretreated with Entecavir

Drug: Vemliver tablet

Comparator group

ACTIVE COMPARATOR

Chronic Hepatitis B patients who pretreated with Entecavir

Drug: Baracross Tablet

Interventions

Vemliver tablet DRUG

Chronic Hepatitis B Patients Who Pretreated with Entecavir switching to Vemliver tab (Tenofovir Alafenamide Hemitartrate)

Treatment group

Baracross Tablet DRUG

Chronic Hepatitis B Patients Who Pretreated with Entecavir continuting treatement with Baracross Tablet

Comparator group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yoon Jun Kim

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 21, 2023
• Study Start: August 28, 2023
• Primary Completion: February 3, 2025
• Study Completion: February 3, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Locations

KR (1)