HBV-infected Liver Cirrhosis
Conditions
Interventions
Group 2:
Group 3:
Group 1:
Sponsors
Shandong Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years old (inclusive), regardless of gender; 2. Meet the diagnostic criteria of hepatitis B cirrhosis in the 2019 edition of China's Guidelines for the Prevention and Treatment of Chronic Hepatitis B; 3. HBsAg positive; 4. The newly treated patients need to be HBV DNA positive; The level of HBV DNA in patients treated with entecavir or TDF is not limited; 5. Fertile female subjects have negative urine pregnancy test, have no pregnancy plan in the past 2 years and voluntarily take effective contraceptive measures; 6. Willing to participate in this clinical trial, able to understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Received IFN-based anti-HBV treatment within 6 months before screening; Or systematic use of powerful immunomodulators such as adrenocortical hormone and thymosin a for more than 2 weeks within 6 months before screening, or it is expected that this drug will be used during the study; 2. Evidence shows decompensation of liver function, including but not limited to: retest confirmed that TBIL > 10 times ULN or prothrombin activity (PTA) = 40 g/d, female >= 20 g/d, or having a history of heavy drinking in two weeks, the alcohol equivalent is 80 g/d) and/or psychoactive substances, drug abusers and addicts; 12. Pregnant or lactating women; 13. Unable or unwilling to provide informed consent or unable to comply with the test requirements; 14. The researcher judges other situations that are not suitable for the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatitis B virus quantification;Evaluate glomerular filtration rate;Renal tubular function index;Blood lipid level; | — |
Countries
China
Contacts
Public ContactXiaohua Wang
Shandong Public Health Clinical Center
Outcome results
None listed