Liver fibrosis in chronic viral hepatitis B
Conditions
Sponsors
Shuguang Hospital Affiliated With Shanghai University of TCM
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for liver fibrosis of chronic viral hepatitis B; (2) The pathological results of liver biopsy in the first 6 months were in line with Ishak diagnostic criteria for liver fibrosis, and the stages were 2-5; (3) Subjects who have been treated for the first time with entecavir (HBV-DNA positive test) or who have been treated with entecavir for more than 1 year and have HBV-DNA lower than the lower limit of test; (4) It conforms to the TCM syndrome differentiation standard of blood stasis, collaterals and unexhausted dampness-heat syndrome; (5) Age form 18 years to 65 years (including 18 and 65) at the time of informed consent, regardless of gender; (6) Participate in this clinical trial voluntarily, give informed consent and sign informed consent.
Exclusion criteria
Exclusion criteria: (1) 6 months before Screening for interferon-based anti-HBV therapy; (2) 6 months before Screening for systemic use of immunomodulators such as adrenocorticosteroids, thymosin, etc. for more than 2 weeks or expected during the study period, with the exception of corticosteroid nasal spray, inhaled steroids, and/or topical steroids; (3) Evidence of liver function decompensation, including but not limited to: TBIL>5 times ULN or prothrombin activity (PTA) upper limit of normal reference value; (5) Patients with hepatitis A, C, D, E and other hepatitis virus infections, severe non-alcoholic fatty liver disease, autoimmune hepatitis, alcoholic liver disease, drug hepatitis, Wilson disease and hematopathy; (6) Failure of liver puncture or non accurate reading of liver tissue pathology; (7) ALT >= 5 times ULN and/or AST >= 5 times ULN, or serum creatinine (Scr) > upper limit of normal reference value; (8) Poorly controlled diabetes (HbA1c > upper limit of normal reference value); (9) Hypertension of poorly controlled blood pressure after treatment with drug specification (poorly controlled systolic blood pressure or greater 160 mmHg and/or diastolic blood pressure, 100 mmHg or higher), New York, cardiac function class (NYHA) III and above (see annex 2), 6 months before screening happened myocardial infarction and unstable angina, or line within six months of coronary artery intervention treatment or vascular transplantation performer; (10) Screening ECG examination results QTc (QTcF or QTcB) >= 500 ms or II-III degree atrioventricular block and other uncontrolled arrhythmias; (11) HIV-infected persons; (12) Routine blood count: WBC = 40g/d, female >= 20g/d, or history of heavy drinking within 2 weeks, equivalent to alcohol amount > 80g/d) (conversion formula of alcohol amount (g): alcohol amount (m1) * ethanol content (%) * 0.8) and/or psychoactive substances, drug abusers and dependants; (15) Active or suspected malignant tumor or history of malignant tumor within 5 years prior to screening (excluding basal cell carcinoma of skin or carcinoma in situ of cervix); (16) A history of transplantation of major functional organs (such as liver, kidney, lung, heart); (17) Failures are determined by Fibroscan, which is caused by obesity and narrow intercostal space. (18) Allergic constitution or history of severe allergy, especially allergic to experimental drugs and ingredients; (19) Pregnant or lactating women, subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of liver function after treatment compared with baseline;Urinary routine;Hemoglobin a1c;Second liver 5;Serum markers of liver fibrosis;AFP;12-lead electrocardiogram;Adverse events;Changes of LSM after treatment compared with baseline;Routine blood test;Fasting plasma glucose;Prothrombin activity;renal function;Abdominal ultrasound;Conventional stool;HBV-DNA;Pathological changes of liver tissue after treatment;Anti-hav, anti-HCV, anti-HDV, Anti-hev, anti-HIV;liver function;Pregnancy test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Curative effect of TCM Syndrome;Changes of FIB-4 after treatment compared with baseline;Changes of APRI after treatment compared with baseline; | — |
Countries
China
Contacts
Public ContactGao Yueqiu
Shuguang Hospital Affiliated With Shanghai University of TCM
Outcome results
None listed