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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
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.
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
48
Start Date
2026-01-01
Completion Date
2027-01-19
Last Updated
2026-09-11
Healthy Volunteers
No
Conditions
Interventions
Entecavir
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