NCT06000657CompletedPhase 4
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.
Source: ClinicalTrials.gov · Last updated 18 Mar 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 196 (actual)
- First submitted
- 16 Jul 2023
- Start date
- 28 Aug 2023
- Primary completion date
- 3 Feb 2025
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Diseases
- Hepatitis B
- NCT number
- NCT06000657
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 196
- From 28 Aug 2023 to the primary completion date, 3 Feb 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Medical history or surgical (treatment) history at the time of screening visit:
Other illness
- 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.
- 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.
Lab values
- 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:
Other
- ① Individuals diagnosed with substance abuse or alcohol addiction within the past year of screening.
Who the study is looking for
- 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.
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.