RecruitingPhase 4NCT07816094

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

Enrollment

48 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Entecavir for people with hepatitis b. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEntecavir

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


Locations(1)

Bangladesh Medical university

Dhaka, Dhaka Division, Bangladesh

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NCT07816094


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