Chronic hepatitis B
Conditions
Interventions
Maintain ETV/TDF/TAF/TMF treatment:none
ETV replacement for TDF/TAF/TMF treatment:none
TDF/TAF/TMF replacement for ETV treatment:none
ETV combined with TDF/TAF/TMF:none
TDF/TAF/TMF combined with ETV:none
Sponsors
Department of Infectious Diseases, The First Affiliated Hospital of Navy Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. HBeAg-positive chronic hepatitis B patients; 2. Age 18 ~ 65 years old (including 18 and 65 years old); 3. Treatment with nucleos (t) ide analogues for over 48 weeks; 4. 20 IU/ml<HBV DNA<2000 IU/ml; 5. Agree to participate in the study, sign the informed consent, and be able to cooperate with the collection of medical history data and follow-up.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period; 2. Diagnosed with hepatocellular carcinoma by imaging; 3. Patients with decompensated cirrhosis; 4. Co-infection with HCV, HDV, or HIV, or co-autoimmune liver disease, metabolism-related fatty liver disease, or drug-induced liver injury; 5. Received interferon therapy within the last year; 6. Patients currently being treated with immunomodulators, investigational drugs, nephrotoxic drugs, or drugs capable of regulating renal excretion; 7. History of malignant tumors within 5 years prior to screening, except for specific tumors cured by surgical resection; Patients evaluated for possible malignancy 8. Combined with uncontrolled cardiovascular and cerebrovascular disease; 9. Combined with serious systemic infection and other risk factors that may affect clinical treatment; 10. Receiving contraindicated contraindicated drugs and subjects with known hypersensitivity to investigational drugs, metabolites, or formulated excipients; 11.Other factors that the investigator determined were not appropriate for inclusion in the study (such as poor compliance, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of complete virological response at 24 weeks and 48 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| The level of decrease in HBsAg titer at 24 weeks and 48 weeks;The level of decrease in HBeAg titer at 24 weeks and 48 weeks;Rate of ALT recovery at 24 weeks and 48 weeks;Decreased levels of HBV DNA quantification at 24 weeks and 48 weeks;HBcrAg level changes at 24 weeks and 48 weeks; | — |
Countries
China
Contacts
Public ContactXuesong Liang
The First Affiliated Hospital of Navy Military Medical University
Outcome results
None listed