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RECRUITING Phase 4 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07816094

Registry updated: 2026-09-11
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Description

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.

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.

Eligibility criteria

Inclusion Criteria: 1. Age: 18 years or older. 2. HBV-related decompensated cirrhosis of liver based on clinical, biochemical and radiological evidence. 3. Detectable level of HBV DNA irrespective of HBeAg status. Exclusion Criteria: 1. Clinical, biochemical, or radiological evidence of hepatocellular carcinoma. 2. Coinfection with HCV. 3. Patient is ongoing antiviral treatment. 4. Cirrhosis due to other causes. 5. Acute-on-chronic liver failure, defined according to the criteria established by APASL. 6. Pregnancy. 7. Patients with known hypersensitivity or allergy to Entecavir.

Conditions

Hepatitis B

Locations

  • Bangladesh Medical university — Dhaka, Dhaka Division, Bangladesh
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record