Randomized, double blind parallel group, positive control, multi-center trial. Patients will be randomized at 1:1 ratio in group A or group B
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
288
Xiangya hospital
Changsha, Hunan, China
Value of log10 hepatitis B virus (HBV) DNA decreases form baseline.
Time frame: 48 weeks
Histological response
Time frame: 48 weeks
Percent of patients with hepatitis B virus (HBV) DNA below limit of detection (LOD) at week 48 with polymerase chain reaction (PCR) assay.
Time frame: 48 weeks
Percent of patients with normalization of alanine aminotransferase (ALT) at week 48
Time frame: 48 weeks
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