chronic hepatitis B
Conditions
Interventions
Prospective Interferon Cohort:NA
Prospective NAs Monotherapy Cohort:NA
Retrospective Observation Cohort:NA
Retrospective Interferon Cohort:NA
Retrospective NAs Monotherapy Cohort:NA
Sponsors
Tianjin Third Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18–65 years (inclusive), regardless of gender; 2. Documented HBsAg positivity >=6 months or objective evidence of prior chronic hepatitis B diagnosis; 3. Post-interferon consolidation therapy achievement of HBsAg =2 weeks apart) showing HBsAg >=0.05 IU/mL and/or detectable HBV DNA; 5. Voluntary provision of informed consent with demonstrated comprehension.
Exclusion criteria
Exclusion criteria: 1. Immunomodulator Use: Systemic administration of potent immunomodulators (e.g., corticosteroids, thymosin a1) for >2 weeks within 6 months pre-screening or anticipated use during the study (excludes topical/nasal/inhaled corticosteroids). 2. Coexisting Viral Infections: Active hepatitis A, C, D, E, or HIV coinfection. 3. Non-HBV Liver Diseases: Autoimmune hepatitis (ANA >=1:100), PBC, PSC, Wilson’s disease, hemochromatosis; Non-exclusion: Non-alcoholic fatty liver disease (NAFLD). 4. Alcohol Abuse: Chronic: >5 years with ongoing intake (>=40g ethanol/day [M], >=20g/day [F]); Acute: >80g ethanol/day within 2 weeks. 5. Liver Biochemistry: ALT >=10×ULN or total bilirubin >=3×ULN. 6. Decompensated Cirrhosis: Ascites, variceal bleeding, hepatic encephalopathy. 7. Hepatocellular Carcinoma: Prior or current diagnosis. 8. Autoimmune/Immunodeficiency Disorders: Primary immunodeficiency; Systemic autoimmune diseases (e.g., IBD, SLE, RA, MS, scleroderma, Sjögren’s, ITP). 9. Uncontrolled Systemic Conditions: Endocrine: Uncontrolled thyroid disorders/diabetes; Cardiovascular: Hypertension (BP >=140/90mmHg), NYHA Class III+/recent (<=6mo) MI/stroke/PCI, unstable angina, arrhythmias; Hematologic/Renal/Pulmonary/Ophthalmic disorders (e.g., anemia, CKD, COPD, retinal detachment). 10. Hematologic Abnormalities: Hemoglobin <100g/L, ANC <1.5×10?/L, platelets <90×10?/L. 11. Pregnancy/Breastfeeding: Current pregnancy/lactation or planned conception during study. 12. Transplantation/Immunosuppression: Prior or planned organ transplant; Current immunosuppressive therapy. 13. Drug Hypersensitivity: Allergy to investigational product(s)/excipients or contraindications per labeling. 14. Investigator Discretion: Any condition deemed high-risk by investigator. 15. Non-Compliance: Inability/unwillingness to provide consent or adhere to protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg clearance rate at the 48-week re-treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBsAg seroconversion rate and the reduction in HBsAg antigen compared to the baseline level at the 48-week re-treatment period;The clearance rate of HBeAg and the seroconversion rate (for HBeAg-positive patients) at 48 weeks of re-treatment;Percentage of patients achieving HBV DNA < LLOD at the 24th and 48th weeks of re-treatment ( HBV DNA positive);The proportion of patients with different types of recurrence after achieving functional cure with interferon therapy.;Duration of interferon course required for retreated patients to achieve functional cure again;Adverse events; | — |
Countries
China
Contacts
Public ContactHuiling Xiang
Tianjin Third Central Hospital
Outcome results
None listed