Comparison of Viral Suppression With 0.5 mg and 1.0 mg Daily Doses of Entecavir in Decompensated HBV Cirrhosis of Liver

Sponsor
Bangladesh Medical University
Study ID
NCT07816094
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Entecavir — DRUG
    Participants receive oral Entecavir once daily. The dose is either 0.5 mg or 1.0 mg, according to randomized treatment assignment, 24 weeks.

Study Details

This is a prospective, randomized, open-label clinical trial designed to compare the antiviral efficacy and safety of entecavir 0.5 mg once daily versus entecavir 1.0 mg once daily in adult patients with hepatitis B virus (HBV)-related decompensated liver cirrhosis. A total of 48 participants will be randomized equally to the two treatment groups and followed for 24 weeks. The primary outcome is the reduction in serum HBV DNA at week 24. Secondary outcomes include changes in Child-Pugh and MELD scores, HBeAg seroconversion, development or worsening of hepatic decompensation, occurrence of hepatocellular carcinoma, and safety of treatment.

Key Dates

First listed
Sep 11, 2026
Start date
Jan 1, 2026
Status verified
Sep 2026
Primary completion
Jan 19, 2027
Completion
Jan 19, 2027

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Entecavir 0.5 mg
    Participants receive Entecavir 0.5 mg orally once daily for 24 weeks.
  • Active Comparator: Entecavir 1.0 mg
    Participants receive Entecavir 1.0 mg orally once daily for 24 weeks.

Primary Outcome Measure

Change in Serum HBV DNA levels [ Time Frame: Baseline to Week 24 ]

Central Contacts

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