Traditional Chinese Medicine Combined With Entecavir to Treat Refractory Liver Fibrosis in Liver Cirrhosis Due to HBV

This is an interventional treatment trial for Hepatitis B Virus Related Cirrhosis Read More

Inclusion Criteria:

• Hepatitis B history or more than 6 months history of positive HBsAg
• Within 2 years of Entecavir treatment, HBV-DNA is negative but has not reach the clinical endpoint (HBeAg seroconversion or HBsAg loss in HBeAg-positive patients; HBsAg loss or anti-HBs seroconversion in HBeAg-negative patients)
• Age 18-60
• Ishak fibrosis score of the biopsy within 6 months ≥5, no anti-fibrosis drug was taken within 6 months.
• Child-Pugh<7 (Stage A)
• The patient or the patient's guardian agrees to participate the random controlled trial and sign the Informed Consent Form.

Exclusion Criteria:

• Decompensated liver cirrhosis
• HCC
• Liver histology conforming to other chronic liver diseases, such as moderate or severe non-alcoholic fatty liver disease(more than 1/3 steatosis in liver ), chronic hepatitis C, chronic hepatitis D, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, inherited metabolic liver disease, drug or toxic induced liver injury, parasitic infections, alcoholic liver disease.
• Have psychiatric history or uncontrollable epilepsy patient.
• Uncontrollable diabetic patient
• History of hemoglobin disease (such as alpha- or beta-thalassemia, sickle cell disease, spherocytosis) or patients with toxic or autoimmune hemolytic anemia.
• Severe background disease like chronic respiratory failure, circulatory failure, kidney failure etc.
• In situ organ transplantation (such as liver, kidney, lung and heart) or bone marrow transplantation and stem cell transplantation.
• Immunocompromised patients: such as HIV infection or take immunosuppressor or Glucocorticoid (such as cyclosporin, azathioprine, adrenocortical hormone) within 3 months or chemotherapy drugs (such as cyclophosphamide, ammonia and cancer chemotherapy) and radioactive therapy.
• Gestation or lactation period women and women who plan to get pregnant during the study period.
• Patient who are allergy to the experimental drug.
• Using history of other anti-viral drug within 6 months.
• Patients who are participating other trials.
• Other situation where PI thinks the patient should be excluded.