Efficacy and Safety of DA-2802 in Chronic Hepatitis B Patients

• DA-2802 319mg Group: Administration with DA-2802 319mg tablet qd and placebo tablet matching to Viread® 300mg for 0-48 weeks.
• Viread® 300mg Group: Administration with Viread® 300mg tablet qd and placebo tablet matching to DA-2802 319mg for 0-48 weeks.

Inclusion criteria

• Patients with chronic hepatitis B aged 18 years or older
• Subjects who have evidence to demonstrate a history of chronic hepatitis B for at least six months from the time of screening visit
• Subjects who have HBsAg positive test at screening visit
• Subjects who did not receive the hepatitis B treatment, including interferon or pegylated interferon, within 24 weeks of starting the screening test
• Subjects with an ALT of 80 units or more and 10 times lower than the normal upper limit at the time of screening

Exclusion criteria

• Subjects infected with hepatitis C, hepatitis D or human immunodeficiency virus
• Subjects with creatinine clearance of less than 50 ml/min at the screening visit
• At the time of screening visit, alpha-fetoprotein level was higher than 50 ng/ml and related imaging test showed hepatocellular carcinoma
• Subjects with decompensated liver disease who meet the following criteria:

• Total bilirubin levels greater than 2.5 mg/dl
• Prothrombin time is at least 3 seconds longer than normal upper limit
• Serum albumin value less than 30 g/l
• Subjects with a history of ascites, jaundice, bleeding from varicose veins, hepatic encephalopathy, or other signs of liver failure.