chronic hepatitis B
Conditions
Interventions
The TMF treatment group:N/A
Sponsors
The Second Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Must be able to understand and sign written informed consent, which must be obtained before screening; 2. Male and non-pregnant and non-lactating female subjects aged 18-65 years or older (subject to the date of signing informed consent); Serum pregnancy test of female subjects of childbearing age was negative; 3. Documented signs of chronic HBV infection (e.g., HBsAg positive for more than 6 months); 4. Participants who have been treated with ETV for 1 to 3 years will be enrolled in the study; 5. Subjects with 20 <= HBV-DNA < 2,000 IU/mL at screening (including intermittent and continuous low virology); 6. Must be willing and able to comply with all research requirements.
Exclusion criteria
Exclusion criteria: Any one of the following is not eligible: 1. Pregnant women, lactating women or women who plan to become pregnant during the study period; 2. Men and women with reproductive potential who were unwilling to use the "effective" contraceptive method specified in the programme during the study period; 3. Co-infection with HCV, HIV or HDV; Or combined with autoimmune liver disease, metabolism-related fatty liver disease, drug-induced liver injury; 4. Imaging diagnosis of hepatocellular carcinoma (evidence of hepatocellular carcinoma); 5. Patients who have received solid organ or bone marrow transplantation; 6. A history of malignant tumors within 5 years prior to screening, except for specific tumors cured by surgical excision (basal cell skin cancer, etc.); Patients assessed for possible malignancy were not eligible; 7. Currently receiving treatment with immunomodulated agents (such as corticosteroids), investigational drugs, nephrotoxic drugs, or drugs that regulate renal excretion; 8. Kidney, cardiovascular, pulmonary, or neurological diseases considered serious by the investigator; 9. Severe bone diseases (such as osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, chondrosis) or multiple fractures; 10. Subjects receiving contraindicated contraindicated drugs (subjects receiving contraindicated drugs will require a washout period of at least 30 days) and known hypersensitivities to study drugs, metabolites or formulation excipients; 11. Current alcohol or substance abuse, as judged by the investigator, may interfere with compliance with study requirements; 12. Any other clinical conditions or previous treatments that, in the opinion of the investigator, would render the subject unfit to participate in the study or unable to comply with medication requirements; 13. Past or existing clinical liver decompensation (Child-Pugh score >= B);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum Hepatitis B Virus deoxyribonucleic acid; | — |
Secondary
| Measure | Time frame |
|---|---|
| glutamic-pyruvic transaminase;pregenomic RNA (pgRNA);hepatitis B core antigen (HBcrAg);Degree of liver fibrosis;Creatinine clearance;Transient Elastograph; | — |
Countries
China
Contacts
Public ContactHu Peng
The Second Affiliated Hospital of Chongqing Medical University
Outcome results
None listed