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

Phase 4RecruitingNCT07816094

Bangladesh Medical University48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis B

Interventions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age: 18 years or older. 2. HBV-related decompensated cirrhosis of liver based on clinical, biochemical and radiological evidence. 3. Detectable level of HBV DNA irrespective of HBeAg status. Exclusion Criteria: 1. Clinical, biochemical, or radiological evidence of hepatocellular carcinoma. 2. Coinfection with HCV. 3. Patient is ongoing antiviral treatment. 4. Cirrhosis due to other causes. 5. Acute-on-chronic liver failure, defined according to the criteria established by APASL. 6. Pregnancy. 7. Patients with known hypersensitivity or allergy to Entecavir.

Outcomes

Primary Outcomes

Change in Serum HBV DNA levels

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.

Time frame: Baseline to Week 24