A Phase II Clinical Trial of Hydronidone Capsules(F351) in Patients With Liver Fibrosis Induced by HBV Chronic Hepatitis

Inclusion Criteria

• •1. Aged 18-65, all genders.
• •2. History of chronic hepatitis B, HBsAg positive≧six months.
• •3. ALT\<eight-fold ULN (maximum).
• •4. Significant liver fibrosis confirmed by liver biopsy.
• •5. HBeAg positive patients, HBV DNA\>2.0×104 IU/mL (copies/mL); HBeAg negative patients，HBV DNA\>2.0×103 IU/mL (104copies/mL).
• •6. Having not accepted the antiviral therapy with interferon and/or nucleoside analog.
• •7. Having not taken anti-inflammatory drugs to protect liver within 1 month before selection.
• •8. Capable of understanding and signing the informed consent before the study.
• •2. Having suffered massive hemorrhage of gastrointestinal tract within 3 months before selection
• •3. TBiL\>three-fold ULN.
• •4. AFP\>100 ug/L
• •5. PLT≦60×109/L
• •6. PTA\<50%
• •7. Having obvious space-occupying lesion in liver as shown by B ultrasound examination.
• •8. With a portal vein ≧1.2cm wide as shown by B ultrasound examination.
• •9. BMI index\>30.
• •10. The patient who suffered from liver function decompensation hepatic cirrhosis and liver neoplasms.
• •11. The patient with alcoholic, drug-induced, hereditary, immune and other viral and non- viral chronic hepatitis.
• •12. The patient with angiocarpy, lung, kidney, incretion, nerve and blood system disease and mental disease.
• •13. The patient with active peptic ulcer.
• •14. Gestational and breast feeding women.
• •15. The subject is the legal disabled person according to the Law of the People's Republic of China on the Protection of Disabled Persons of the April 2008 edition.
• •16. The subject who participated in other drug tests within recent 3 months.
• •17. The patient who is suspected with poor compliance or disagrees to participate in the test.
• •18. The patient who is considered by other investigators not to be suitable for participating in the study.