CompletedPhase 4

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

South Korea196 participantsStarted 2023-08-28

Plain-language 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.

Who can participate

Age range19 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

HBV viral suppression rate

Timeframe: 48 weeks

Trial details

NCT IDNCT06000657

SponsorDaewoong Pharmaceutical Co. LTD.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-02-03

View on ClinicalTrials.gov More Hepatitis B, Chronic trials