Asses the efficacy and safety of the Anti hepatitis B placenta transfer factor injection in the treatment of HBeAg positive chronic hepatitis B.
This study using entecavir tablets as basic therapy, is a randomized, double-blind, placebo-controlled multi center study, including the screening period (-4 weeks), baseline and treatment period (96 weeks). The treatment period of first 48 weeks, using entecavir tablets as basic treatment, placebo-controlled trials; the second 48 weeks, taking entecavir tablets alone, continue observation experiment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
288
Anti-HBV Placenta Transfer Factor Injection: 2mg/4ml, intramuscular injection, the 0-24 week, once every other day; week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks
Physiological saline injection: 2mg/4ml, intramuscular injection,the 0-24 week, once every other day, week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks
HBeAg serum conversion rate
The HBeAg serum conversion rate of the Test Group and the Control Group after 48 weeks treatment
Time frame: Week 48
HBeAg serum conversion rate
The HBeAg serum conversion rate of the Test Group and the Control Group for treatment week 24, week 72
Time frame: Week 24, 72
HBeAg disappearance rate
The HBeAg disappearance rate of the Test Group and the Control Group for treatment week 24, week 48 and week 72
Time frame: Week 24, 48 and 72
HBV DNA titer
The proportion of subjects for each observation point in HBV DNA titer decreased 2 logarithmic
Time frame: Week-4, 0,12,24,48,72 and 96
The proportion of subjects for the HBV DNA can not be detected
The proportion of subjects for the HBV DNA can not be detected in treatment week 24, week 48 and week 72
Time frame: Week 24, 48 and 72
HBeAg and HBsAg titer
The changes of HBeAg and HBsAg titer at each observation point
Time frame: Week-4, 0,12,24,48,72 and 96
The quantitative changes of anti -HBc
The quantitative changes of anti -HBc in each observation point
Time frame: Week-4, 0,12,24,48,72 and 96
The variation of ALT
The variation of ALT in each observation point
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Time frame: Week-4,24,48,72 and 96
The seroconversion rate of HBsAb and HBeAb
The seroconversion rate of HBsAb and HBeAb in each observation point
Time frame: Week-4, 0,12,24,48,72 and 96
The resistance mutation rate of HBsAb and HBeAb
The resistance mutation ncidence of HBsAb and HBeAb in each observation point
Time frame: Week-4, 0,12,24,48,72 and 96
The cumulative incidence of virologic breakthroughrate of HBsAb and HBeAb
The cumulative incidence of virologic breakthroughrate of HBsAb and HBeAb in each observation point
Time frame: Week-4, 0,12,24,48,72 and 96
The changes of relative immune parameters of the transfer factor in peripheral blood(the number of T lymphocytes and the expression levels of cytokines)
The changes of relative immune parameters of the transfer factor in peripheral blood
Time frame: Week 0, 12, 24, 48, 72, 96