Chronic hepatitis B
Conditions
Interventions
HBeAg positive group:None
HBeAg negative group:None
Sponsors
The First People's Hospital Of Neijiang
Eligibility
Sex/Gender
All
Age
12 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary enrollment, able to understand and voluntarily sign the informed consent form; 2. Age:12-65 years (including 12 and 65), gender is not limited; 3. HBsAg+ medical history of at least 6 months (HBeAg+/-); 4. HBsAg <= 1500 IU/mL at screening; 5. ALT<=5×ULN and TBIL<=2×ULN at screening; 6. Subjects should use effective contraception during the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant women or women scheduled for pregnancy and lactation; 2. those who have received standardized treatment with interferon-based products (defined as interferon use for more than 3 consecutive months) within 6 months prior to screening; 3. other causes of chronic liver disease, e.g. due to alcoholism, autoimmune liver disease; 4. evidence of acute severe liver damage: e.g. ALT > 10 ULN, or total bilirubin > 2 ULN; 5. those with evidence of decompensated liver disease: e.g., ascites, ruptured esophagogastric variceal hemorrhage, sepsis, hepatic encephalopathy, hepatorenal syndrome; or previous evidence of decompensated cirrhosis; compensated cirrhosis; 6. confirmed or suspected hepatocellular carcinoma and other malignant tumors; 7. the presence of serious lesions of vital organs such as cardiovascular, pulmonary, renal and cerebral pathologies; 8. participation in other interventional trial studies within 3 months prior to screening or other conditions deemed inappropriate for enrollment by the investigator; 9. autoimmune diseases, including psoriasis, systemic lupus erythematosus, etc; 10. endocrine system disorders, including thyroid disease, diabetes mellitus, etc; 11. those with severe retinopathy or other serious eye diseases; 12. those who plan to receive organ transplantation or have already undergone organ transplantation; 13. those who are allergic to interferon, entecavir, tenofovir, tenofovir disoproxil fumarate, or drug excipients, or who meet any of the contraindications in the instructions for the experimental drug; 14. in the opinion of the supervising physician, there are other circumstances in which the use of interferon is contraindicated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg clearance rate;Extent of HBsAg reduction from baseline;Degree of reduction in HBV DNA from baseline;Complete virologic response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBeAg serologic conversion rate;Change from baseline in liver function markers (ALT, AST, PLT, TBIL, etc.);Change from baseline in LSM;Changes in liver stiffness;Incidence of liver cancer; | — |
Countries
China
Contacts
Public ContactXin Chen
The First People's Hospital Of Neijiang
Outcome results
None listed