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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
118
Asan Medical Center
Seoul, South Korea
the Difference between HBV DNA level(log10) and the base line of HBV DNA level(log10)
measured at 24th week of the administration
Time frame: 52 weeks
the percentage of participants who have less than 300 copies/ml of HBV DNA (undetectable titre)
measured at 24th/48th week of the administration
Time frame: 52 weeks
the proportion of participants with normalization of serum alanine aminotransferase (less than 1.0 times the upper limit of normal)
measured at 24th/48th week of the administration
Time frame: 52 weeks
the percentage of participants who have lost HBeAg
HBeAg of the participants was found positive at their screening visit. Also, the measurement performs 24th/48th week of the administration.
Time frame: 52 weeks
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