Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.
The purpose of this study is to evaluate the non-inferiority and safety in terms of HBV DNA undetectability comparing Baraclude Tab. in HBeAg(+) chronic hepatitis B patients treated with long-term Baraclude Tab.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
15 Sites
Seoul, South Korea
RECRUITINGThe proportion of patients with maintenance of HBV DNA undetectability
analysis
Time frame: 48weeks
The proportion of patients with HBeAg seroconversion
analysis
Time frame: at week 12, 24, 36 and 48 of treatment
The proportion of patients with HBeAg seroclearance
analysis
Time frame: at week 12, 24, 36 and 48 of treatment
The proportion with HBsAg seroclearance
analysis
Time frame: at week 48 of treatment
The proportion with HBeAg seroconversion and HBsAb positive
analysis
Time frame: at week 48 of treatment
Changes in serum HBV DNA levels
analysis
Time frame: at week 48 of treatment
Changes in HBsAg titer
analysis
Time frame: at week 48 of treatment
Changes in ALanine amino Transferase (ALT)
analysis
Time frame: at week 48 of treatment
Proportion of patients with virologic breakthrough
virologic breakthrough is defined as the increase in serum HBV DNA (\>60IU/ml) as determined by at least 2 consecutive measurements of at least 3 month apart, during continued treatment
Hanmi Pharmaceutical
CONTACT
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Time frame: at week 48 of treatment
Changes in EuroQoL Five Dimensions Questionnaire-3L(EQ-5D-3L)
questionnaire
Time frame: at week 48 of treatment