The purpose of the study is to investigate the safety and the antiviral activity of two doses of LB80380 for 48 weeks in treatment-naive patients with chronic hepatitis B infection compared to entecavir 0.5 mg.

LB80380, an oral prodrug, is a promising candidate nucleotide analogue with antiviral activity against wild-type HBV. LB80380 is undergoing clinical development by LG Life Sciences for use in the treatment of chronic HBV infection.

In this study, the treatment period is 48-week with 24-week of follow-up period.

Inclusion Criteria:

• Female or male, 18 to 65 years of age, inclusive
• Chronic hepatitis B
• Not treated with anti-viral therapeutics including interferon or pegylated interferons for more than 12 weeks before Screening
• Not treated with anti-viral therapeutics including interferon or pegylated interferons 6 months within Screening
• Compensated chronic hepatitis B
• HBeAg positive or HBeAg negative
• Elevated serum ALT level (1.2-10 X ULN, inclusive)

Exclusion Criteria:

• Co-infection with hepatitis C or D virus (HCV or HDV) or HIV
• Decompensated liver disease
• Creatinine clearance (calculated by Cockroft-Gault formula) less than 50 ml/min
• Screening alpha-fetoprotein (AFP) value greater than or equal to 50 ng/mL, and a follow-up ultrasonography performed prior to baseline shows findings indicative of HCC
• Treatment with immunomodulatory agent or corticosteroids within 6 months prior to study entry.
• Pregnancy or breast-feeding
• Patient is currently abusing alcohol or illicit drugs
• Significant systemic illnesses other than liver diseases
• Presence of other causes of liver disease
• A history of organ transplantation

Presence of anti-HBs at screening