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NCT Number: NCT07816094

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

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.

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Key information

Conditions

Hepatitis B Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Bangladesh Medical university

Dhaka, Dhaka Division, 1000, Bangladesh

Location status: Recruiting

Location contact

Hanif Uddin, MBBS

CONTACT

[email protected]

+8801710099830

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 years or older.
  • HBV-related decompensated cirrhosis of liver based on clinical, biochemical and radiological evidence.
  • Detectable level of HBV DNA irrespective of HBeAg status.

Exclusion criteria

  • Clinical, biochemical, or radiological evidence of hepatocellular carcinoma.
  • Coinfection with HCV.
  • Patient is ongoing antiviral treatment.
  • Cirrhosis due to other causes.
  • Acute-on-chronic liver failure, defined according to the criteria established by APASL.
  • Pregnancy.
  • Patients with known hypersensitivity or allergy to Entecavir.

Treatment and study plan

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.

Primary outcomes

  1. Change in Serum HBV DNA levels

    Time frame: Baseline to Week 24

    Comparison of the reduction in serum HBV DNA (IU/mL) from baseline to 24 weeks between receiving Entecavir 0.5 mg/day and 1.0 mg/day.

Study contacts

Contact information is provided by the study sponsor or research team.

Hanif Uddin, MBBS

CONTACT

[email protected]

+8801710099830

Sponsors and collaborators

Lead sponsor

Bangladesh Medical University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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