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

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 :

• Negative conversion ratio of HBV DNA after treatment (HBV DNA<1×103copies/mL) and falling range.
• The falling proportion of Fibrocan Kpa value after treatment compared with that before treatment.
• The falling proportion that decreases not less than 1 level and progression-free fibrosis after treatment compared with that before treatment.
• The improvement of ALT of liver function.

Inclusion criteria

• Aged 18-65, all genders.
• History of chronic hepatitis B, HBsAg positive≧six months.
• ALT<eight-fold ULN (maximum).
• Significant liver fibrosis confirmed by liver biopsy.
• HBeAg positive patients, HBV DNA>2.0×104 IU/mL (copies/mL); HBeAg negative patients，HBV DNA>2.0×103 IU/mL (104copies/mL).
• Having not accepted the antiviral therapy with interferon and/or nucleoside analog.
• Having not taken anti-inflammatory drugs to protect liver within 1 month before selection.
• Capable of understanding and signing the informed consent before the study.

Exclusion criteria

• Failing to meet any one requirement of the inclusion criteria.
• Having suffered massive hemorrhage of gastrointestinal tract within 3 months before selection
• TBiL>three-fold ULN.
• AFP>100 ug/L
• PLT≦60×109/L
• PTA<50%
• Having obvious space-occupying lesion in liver as shown by B ultrasound examination.
• With a portal vein ≧1.2cm wide as shown by B ultrasound examination.
• BMI index>30.
• The patient who suffered from liver function decompensation hepatic cirrhosis and liver neoplasms.
• The patient with alcoholic, drug-induced, hereditary, immune and other viral and non- viral chronic hepatitis.
• The patient with angiocarpy, lung, kidney, incretion, nerve and blood system disease and mental disease.
• The patient with active peptic ulcer.
• Gestational and breast feeding women.
• 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.
• The subject who participated in other drug tests within recent 3 months.
• The patient who is suspected with poor compliance or disagrees to participate in the test.
• The patient who is considered by other investigators not to be suitable for participating in the study.