The Efficacy and Safety of Switching to Vemliver Tab From Entecavir in Chronic Hepatitis B Patients Who Pretreated With Entecavir

Hepatitis B, Chronic Clinical Trial

Official title:

The Efficacy and Safety of Switching to Vemliver Tab (Tenofovir Alafenamide Hemitartrate) From Entecavir in Chronic Hepatitis B Patients Who Pretreated With Entecavir; A Multi-Center, Randomized, Open-Label, Active-Controlled, Non-Inferiority, Phase IV Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06000657
• Other study ID #: DWVMLV_P401
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: August 28, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2024
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 and 48 weeks visits.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 196
• Est. completion date: December 31, 2025
• Est. primary completion date: September 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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:

? 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:

? 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. ? 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:

? Co-infection with HCV and HIV.

• Hemoglobin <8 g/dL.

• Impaired renal function. ? 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. ? Anti-HBV drugs other than investigational medicinal products. ? Hepatotonics.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Vemliver tablet
Chronic Hepatitis B Patients Who Pretreated with Entecavir switching to Vemliver tab (Tenofovir Alafenamide Hemitartrate)
• Baracross Tablet
Chronic Hepatitis B Patients Who Pretreated with Entecavir continuting treatement with Baracross Tablet

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV viral suppression rate	HBV viral suppression rate at 48 weeks post-baseline	48 weeks
Secondary	HBV viral suppression rate	HBV viral suppression rate at 24 weeks post-baseline	24 weeks
Secondary	ALT normalization rate	ALT normalization rate at 24 weeks post-baseline	24 weeks
Secondary	ALT normalization rate	ALT normalization rate at 48 weeks post-baseline	48 weeks
Secondary	Change from baseline in ALT	Change from baseline in ALT at 24 weeks post-baseline	24 weeks
Secondary	Change from baseline in ALT	Change from baseline in ALT at 48 weeks post-baseline	48 weeks