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Randomed and Double-blinded Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Beijing, China
Start Date
June 25, 2015
Primary Completion Date
November 20, 2020
Completion Date
November 20, 2020
Last Updated
June 23, 2022
168
ACTUAL participants
Hydronidone
DRUG
Placebo
DRUG
Entecavir
DRUG
Lead Sponsor
Shanghai Genomics, Inc.
NCT04166266
NCT06550622
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT05922306