Status:
COMPLETED
Efficacy and Safety of Switching to Vemliver From Entecavir in Chronic Hepatitis B Patients Previously Treated With Entecavir
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Hepatitis B, Chronic
Eligibility:
All Genders
19+ years
Phase:
PHASE4
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 a...
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 selec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2025
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT06000657
Start Date
August 28 2023
End Date
February 3 2025
Last Update
March 18 2025
Active Locations (1)
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1
Seoul National University Hospital
Seoul, South Korea