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

• Status: Completed
• Trial end date: 2015-11-06
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-A Pharmaceutical Co., Ltd.; Dong-A ST Co., Ltd.
• Treatments: Entecavir

Criteria

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