Compares two entecavir doses in advanced hepatitis B liver disease
Compares lower and higher entecavir doses in adults with hepatitis B cirrhosis.
Plain-language title generated from the registry record
Registry title: Comparison of Viral Suppression With 0.5 mg and 1.0 mg Daily Doses of Entecavir in Decompensated HBV Cirrhosis of Liver
Key facts
- Where
- Dhaka, BangladeshSee the site
- Phase
- Phase 4
Where in Bangladesh
- Bangladesh Medical UniversityDhaka, BangladeshTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bangladesh Medical University
- Trial code
- NCT07816094
- Record updated
- 11 September 2026
- Original 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.Read full original descriptionShow less
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.
Inclusion: 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: Coinfection with HCV; Acute-on-chronic liver failure, defined according to the criteria established by APASL; Patients with known hypersensitivity or allergy to Entecavir; Clinical, biochemical, or radiological evidence of hepatocellular carcinoma; Patient is ongoing antiviral treatment; Cirrhosis due to other causes; Pregnancy.