Study of Entecavir for Reducing the Risk of Hepatocellular Carcinoma in Chronic Hepatitis B Patients

Inclusion Criteria:

• A subject who has consented to participate in this clinical trial
• A subject aged between ≥20 to ≤75 years old
• A subject with positive HBsAg for more than 24 weeks (may be confirmed by medicalhistory)
• HBV DNA ≥26 IU/mL or ≤ 2,000 IU/mL at the time of screening
• A subject diagnosed with cirrhosis with one of the following:

1. Subject with confirmed liver cirrhosis in the screening period or liver biopsyperformed within 1 year from the time of screening (METAVIR score> 3, ISHAKscore> 4)
2. Two or more confirmed typical findings suggesting liver cirrhosis from imagingsuch as liver ultrasound and CT performed within 24 weeks of screening or duringscreening period (nodularity of the liver surface, atrophy of the inner right andleft lobes, thickening of the left and tail lobes, hepatic portal systemexpansion of surrounding space, expansion of hepatic portal system (>1.3 cm) andsplenomegaly (>12 cm))
3. One or more confirmed typical findings suggesting liver cirrhosis from imagingsuch as liver ultrasound and CT performed within 24 weeks of screening or duringscreening period (nodularity of the liver surface, atrophy of the inner right andleft lobes, thickening of the left and tail lobes, hepatic portal systemexpansion of surrounding space, expansion of hepatic portal system (>1.3 cm) andsplenomegaly (>12 cm)) or findings including the following:

• Confirmed thrombocytopenia (<150,000/mm3) at the screening period or blood testsconducted within 24 weeks from the time of screening
• Confirmed identification of esophageal varicose veins or gastric varicose veins byendoscopy or CT performed within one year from the screening period or at screening
• Liver stiffness measurement (LSM)> 11.5 kilopascal (kPa) (F4) as a result of liverfibrosis scan, performed within 1 year from screening period or at screening

Exclusion Criteria:

• A subject with non compensated cirrhosis and any of the following:

1. Serum bilirubin> 3 mg/dL
2. Prothrombin time> 6 seconds prolonged or International Normalized Ratio (INR) >1.6
3. Serum albumin <2.8 g/dL
4. History of ascites, varicose bleeding, hepatorenal syndrome, hepaticencephalopathy (hepatic coma) requiring treatment within 5 years from screening
5. Child-Pugh score ≥ 8

• A subject who have received interferon or other oral nucleic acid analogues (nucleos(t)ide analogues) (However, if the treatment duration was less than 30 days inthe past and the treatment was treated 24 weeks before the screening, participation ispossible)
• A subject diagnosed with liver cancer in the past or present
• Renal function decline (creatinine clearance <50 mL/min, estimated by theCockcroft-Gault formula)
• A subject with serious concomitant diseases such as congestive heart failure, chronickidney disease, blood disease, or malignant tumors in the past or present
• A subject infected with hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
• A subject who consume excessive alcohol (men: 30g/day or more, women: 20g/day or more)
• A subject with liver diseases such as autoimmune hepatitis, hemochromatosis, orWilson's disease
• Pregnant or breastfeeding women
• Previous organ transplant recipients
• A subject unable to complete the clinical trial or to have any medical condition thatmay interfere with the evaluation of the efficacy of this clinical trial