Entecavir 0.5 mg vs 1.0 mg daily in adults with HBV-related decompensated cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, open-label study comparing two daily doses of entecavir in adults with HBV-related decompensated liver cirrhosis. A total of 48 participants will be assigned equally to the 0.5 mg and 1.0 mg groups and followed for 24 weeks. The primary endpoint is the change in serum HBV DNA at week 24, with secondary outcomes including changes in Child-Pugh and MELD scores, HBeAg seroconversion, progression of hepatic decompensation, incidence of hepatocellular carcinoma, and overall safety. Eligible participants are adults with HBV-related decompensation, detectable HBV DNA, and no evidence of hepatocellular carcinoma or co-infections.

Why it matters

Who can join: the full rules

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.

Where it's running

• Bangladesh Medical university
  Dhaka, Dhaka Division, Bangladesh Recruiting

Study contacts

• Study coordinator: Hanif Uddin, MBBS
• Email: mdhanifuddin173@gmail.com
• Phone: +8801710099830

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.