Baracle Tab. ® Versus Baraclude Tab.® for Patients With HBeAg Chronic Hepatitis B

A Multicenter, Double-blind, Active-controlled, Randomized, Parallel Group Study to Demonstrate the Comparison and Evaluation of Baracle Tab.® and Baraclude Tab.® for HBeAG Chronic Hepatitis B

This is a multicenter, double blind, active-controlled, randomized, parallel group study to demonstrate the anti-viral activity and safety of Baracle Tab. and Baraclude Tab. for patients with HBeAg Chronic Hepatitis B. The subject will receive two tablets daily for 48 days.

Inclusion Criteria:

• Subjects with HbeAg Chronic Hepatitis B for at least six months starting from the Screening visit
• Subjects with HBsAg-Positive diagnosed at the screening visit
• Subjects with HBeAg-Positive or HBeAg-negative diagnosed at the screening visit
• For those who were diagnosed HBeAg-Positive, HBV DNA level should be equal or more than 1x10^5 copies/ml
• For those who were diagnosed HBeAg-Negative, HBV DNA level should be equal or more than 1x10^5 copies/ml
• Subjects who were NOT administrated any anti-viral agents including interferon or pegylated interferon

Exclusion Criteria:

• Subjects with HCV, HDV or HIV
• Subjects with decompensated liver disease who have more than 2.5mg/dl of total bilirubin, longer than 3 seconds of prothrombin time, less than 30g/l of serum albumin
• With medical history of hemorrhage, hepatic encephalopathy, or dyshepatia due to ascites, jaundice, varicose vein
• Less than 50ml/min of creatinine clearance diagnosed at the screening visit
• More than 50 ng/ml of alpha-fetoprotein at the screening visit
• Involved in other studies