NCT07816094RecruitingPhase 4
Comparison of Viral Suppression With 0.5 mg and 1.0 mg Daily Doses of Entecavir in Decompensated HBV Cirrhosis of Liver
Source: ClinicalTrials.gov · Last updated 11 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- First submitted
- 7 Sept 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 19 Jan 2027
- Lead sponsor
- Bangladesh Medical University
- Diseases
- Hepatitis B
- NCT number
- NCT07816094
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 48
- From 1 Jan 2026 to the primary completion date, 19 Jan 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Coinfection with HCV.
- Acute-on-chronic liver failure, defined according to the criteria established by APASL.
- Patients with known hypersensitivity or allergy to Entecavir.
Other
- Clinical, biochemical, or radiological evidence of hepatocellular carcinoma.
- Patient is ongoing antiviral treatment.
- Cirrhosis due to other causes.
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bangladesh Medical University Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.