Hydronidone for the Treatment of Liver Fibrosis Associated with Chronic Viral Hepatitis B Phase 3 Trial.

Inclusion Criteria:

1. Age from 18 to 65 years old (including 18 and 65 years old, based on the time ofsigning the written informed consent); gender is not limited.

2. History of chronic hepatitis B and/or hepatitis B surface antigen (HBsAg) positive≥6months.

3. Percutaneous liver biopsy confirmed liver fibrosis (Ishak score ≥3).

4. Positive HBV DNA.

5. ALT < 8 x ULN (standard upper limit).

6. No antiviral therapy with interferon and/or nucleoside analogues within 3 monthsprior to enrollment.

7. 3 months before inclusion, he/she had not received any of the following proprietaryChinese medicines that may have anti-fibrosis effects: Fuzheng Huayu Capsule (tablet), Anluo Huayu Pill, compound Bijiaruangan tablet, etc.

8. The subject (or his/her sexual partner) had no pregnancy plan during the trialperiod and within 6 months after the trial, voluntarily used effective physicalcontraception, and had no sperm or egg donation plan.

9. Before the trial, they have understood the nature, significance, potential benefits,inconvenience and potential dangers of the trial in detail, and have voluntarilyparticipated in the clinical trial, have good communication with the researchers,comply with the requirements of the whole study, and have signed a written informedconsent form.

Exclusion Criteria:

1. Massive upper gastrointestinal hemorrhage within 3 months before enrolment.

2. Total bilirubin (TBiL) > 3×ULN, or 3×ULN < ALT < 8×ULN and TBiL > 2×ULN.

3. AFP > 100 μg/L although there was no indication of liver cancer.

4. Platelets (PLT) ≤60×109/L.

5. Prothrombin activity (PTA) < 50% or INR > 1.5.

6. Imaging showed obvious space-occupying lesions in the liver, suggesting tumor.

7. Body mass index (BMI) > 30 kg/m2.

8. Patients with decompensated liver cirrhosis and liver malignant tumor.

9. Patients with chronic hepatitis C or non-viral (alcoholic, non-alcoholic, drug,etc.) chronic hepatitis.

10. Serious diseases of cardiovascular, pulmonary, renal, endocrine, neurological andhaematological systems, as well as mental disorders .

11. Women who are pregnant and/or breastfeeding.

12. Have participated in clinical trials of other drugs in the last 3 months.

13. The Investigator considers that there are any conditions that may affect thesubjects' informed consent or adherence to the study protocol, or participation inthe study may affect the study results or their own safety.