Chronic hepatitis B
Conditions
Interventions
Early non-response group and early response group:1. Early Non-Responder Group
During the Phase 1 treatment period (24 weeks), all enrolled patients received nucleos(t)ide analogues (NA, monotherapy o
Sponsors
920th Hospital of the Joint Logistics Support Force, PLA
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Age must be >=18 years old and <=60 years old, gender unrestricted; 2. HBsAg positive history for at least 6 months or other a previous diagnosis of chronic hepatitis B; 3. HBsAg quantitative test value at enrollment is between 100-10000 IU/mL (inclusive of); 4. HBV DNA<100 IU/mL; 5. Not using interferon therapy within six months; 6. Voluntary participation in this study, able to understand and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Systemic use of potent immunomodulators such as adrenal cortical hormones, thymosin a1, etc. for more than 2 weeks within 6 months prior to screening, or the expected use of such drugs during the study period, except for treatments such as corticosteroid nasal sprays, inhaled steroids and/or topical steroids; 2. Evidence of acute severe liver damage: such as ALT >10 ULN, or ALT significantly elevated accompanied by markedly increased bilirubin (TBIL>=2ULN); 3. Liver cirrhosis patients; 4. Evidence of malignant tumor presence; 5. Complicated with autoimmune liver disease, alcoholic liver disease, or other types of viral hepatitis or HIV co infected individuals; 6. There are patients with underlying cardiovascular, cerebrovascular, pulmonary, and renal diseases that require effective control; 7. Patients with neuropsychiatric disorders, especially those with a history of mental illnesses such as depression, anxiety, mania, schizophrenia, or a family history of mental disorders (particularly a history of or depressive; 8. Anemic patients with absolute neutrophil count<0.75 × 10^9/L, platelet count<100 × 10^9/L, or moderate or above (hemoglobin below 90g/L); 9. Autoimmune diseases, including psoriasis, systemic lupus erythematosus, etc; 10. People with endocrine system diseases not effectively controlled, including thyroid diseases, diabetes, etc; 11. Individuals with severe retinal lesions or other serious ophthalmic diseases; 12. Individuals who plan to receive organ transplantation or have already undergone organ transplantation; 13. Individuals with a history of allergy to nucleoside (acid) analogues or contraindications to their use; 14. Individuals with a history of IFN allergy or contraindications to use; 15. Pregnant, lactating women, or those with a fertility plan within 2 years; 16. Patients who require long-term use of anticoagulant drugs; 17. Other situations that have participated in other intervention trials or are deemed unsuitable for inclusion by the researcher within the previous 3 months of screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatitis B surface antigen (HBsAg) seroclearance rate at end of treatment;Hepatitis B surface antigen (HBsAg) seroclearance rate at 24 weeks post-treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in hepatitis B surface antigen (HBsAg) level from baseline at end of treatment;Reduction in hepatitis B surface antigen (HBsAg) level from baseline at 24 weeks post-treatment; | — |
Countries
China
Contacts
Public ContactMa Shiwu
920th Hospital of the Joint Logistics Support Force, PLA
Outcome results
None listed