Hepatitis B
Conditions
Brief 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.
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.
Sponsors
Bangladesh Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum HBV DNA levels | Baseline to Week 24 | 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. |
Countries
Bangladesh
Contacts
CONTACTHanif Uddin, MBBS
Outcome results
None listed