To explore the effective dose and safety of the effect of hydronidone and entecavir on hepatic fibrosis in chronic viral hepatitis B.
Primary observation indexes: Hepatic fibrosis Ishak score after treatment decreases by the proportion not less than 1 compared with that before treatment. Secondary observation indexes : 1. Negative conversion ratio of HBV DNA after treatment (HBV DNA\<1×103copies/mL) and falling range. 2. The falling proportion of Fibrocan Kpa value after treatment compared with that before treatment. 3. The falling proportion that decreases not less than 1 level and progression-free fibrosis after treatment compared with that before treatment. 4. The improvement of ALT of liver function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
168
The investigational products in the test groups and control group shall be orally taken 30 minutes before meals for 52 continuous weeks. There are respectively 60 cases in the test group I, II, III and the control group, totally 240 cases.
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Unnamed facility
Beijing, China
Changes in hepatic fibrosis in chronic viral hepatitis B
Time frame: one year
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