Health Condition 1: K740- Hepatic fibrosis
Conditions
Interventions
Intervention1: 0.5 mg arm: Participants in this arm will be given 0.5 mg dose of entecavir once daily
Control Intervention1: 1.0 mg arm: Participants in this arm will be given 1.0 mg dose of entecavir
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. HBsAg positive 2. hemodynamic stable 3. liver cirrhosis 4. presenting with first decompensation or Child-Tutcott-Pugh (CTP) score seven or more 5. either treatment naïve or had used antivirals for less than 3 months duration 6. had detectable HBV DNA (over 50 IU/mL) at the time of start of antiviral. Cirrhosis will be diagnosed with a combination of evidences on clinical, biochemical, radiological, and endoscopic examination. First decompensation of cirrhosis will be defined according to the most recent definition given by BAVENO VII consensus guideline. It defines first decompensation by occurrence of either overt ascites (or pleural effusion) with increased serum ascites albumin gradient [over 1.1 g/dl], or overt hepatic encephalopathy (West Haven grade II or more) or variceal bleeding
Exclusion criteria
Exclusion criteria: a. prior use of antivirals for >3 months b. suspected or confirmed hepatocellular carcinoma c. hepatitis C virus viremia d. HIV coinfection e. active alcohol intake ( >30 g for men and 20 g for women daily) f. concomitant hepatobiliary disease g. use of immunosuppressive medication, regardless of dose, indication, and drug h. present or prior malignancy, regardless of its site, nature, and stage i. pre-existing chronic kidney disease, regardless of its etiology, with eGFR j. Hepatorenal syndrome k. acute on chronic liver failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the proportion of participants achieveing a â??composite primary end pointâ?? (further decompensation or hepatocellular carcinoma or liver related death) in 12 months of follow-up.Timepoint: 12 months from the time of start of entecavir after inclusion in our study | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the proportion of participants who could achieve complete viral suppression (HBV DNA 50 IU/mL)Timepoint: 12 months from the time of start of entecavir after inclusion in our study;Compare the mean reduction in HBV DNA levelTimepoint: at 3, 6, 9, & 12 months from the time of start of entecavir after inclusion in our study;Proportion of HBeAg positive participants who could seroconvert to HBeAg negative statusTimepoint: 12 months from the time of start of entecavir after inclusion in our study | — |
Countries
India
Contacts
Public ContactAmit Goel
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Outcome results
None listed