The decompensation stage of hepatitis B cirrhosis
Conditions
Interventions
experimental group:Oral TAF25mg/day
Sponsors
Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Patients with decompensated hepatitis B cirrhosis who meet the diagnostic criteria of Guidelines for Prevention and Treatment of Chronic Hepatitis B (2019 edition); 2.The applicant shall be 18 to 65 years old (including 18 and 65 years old), regardless of gender; 3.HBV DNA or HBV DNA negative, but HBsAg positive; 4.Patients who agree to participate in the clinical trial and voluntarily sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with other liver diseases, including chronic viral hepatitis C, chronic alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease (according to the criteria of each clinical unit, the positive ANA titer meeting the diagnostic criteria), and patients with liver failure and primary hepatocellular carcinoma. 2. Patients with severe diseases of the heart, blood, respiratory system and central nervous system. 3. The clearance rate of creatinine before chronic renal disease or inclusion was less than 60ml/min. 4. Anti-HIV positive. 5. Severe bone disease (such as osteomalacia, chronic osteomyelitis, osteogenic imperfections, rickets) or multiple fractures. 6. Patients with pancreatitis or a history of malignancy within 5 years (except for cervical epithelial carcinoma, squamous carcinoma, or basal cell carcinoma of the skin that was clinically cured within 5 years of diagnosis). 7. People who plan to receive organ transplantation or have already received organ transplantation. 8. Patients with disabilities stipulated by law (blind, deaf, dumb, intellectual and mental disorders, etc.). 9. Have a history of alcohol or drug abuse within the last 1 year. 10. Pregnant women, lactating women or recent family planning. 11. Patients who have participated in clinical trials of other drugs within the last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Highly sensitive HBV DNA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bone mineral density values;eGFR/serum creatinine;HBeAg negative transfer;Serological conversion rate of HBeAg;Serological conversion rate of HBsAg;FIB - 4 index;Blood fat; | — |
Countries
China
Contacts
Public ContactWang Xiaozhong
Hospital of Traditional Chinese Medicine of Xinjiang Uygur Autonomous Region
Outcome results
None listed