Chronic Hepatitis B
Conditions
Interventions
Observation (Control Arm):untreated control
PegIFNa Monotherapy Arm:Pegylated interferon alfa (PegIFNa) 135 µg/week, subcutaneous injection (SC)
PegIFNa + HBV Vaccine Combination Arm:PegIFNa 135 µg/week, SC Combined with recombinant hepatitis B vaccine 60 µg every 2 weeks, intramuscular injection (IM)
Sponsors
Beijing You An Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-60 years (inclusive); 2.Chronic hepatitis B (CHB) patients with documented serum HBsAg positivity and/or HBV DNA positivity for >6 months; 3.Achieved HBsAg seroclearance (HBsAg =1 week) during continuous PegIFNa therapy (24-96 weeks, with or without nucleos(t)ide analogs [NAs]); 4.Serum HBeAg-negative.Serum HBV DNA <10 IU/mL; 5.Serum anti-HBs <10 IU/mL; 6.No pregnancy plans within 6 months after study completion; 7.Good compliance and voluntary provision of written informed consent.
Exclusion criteria
Exclusion criteria: 1.Current or previous diagnosis of liver cirrhosis; 2.Spontaneous HBsAg seroclearance or HBsAg loss achieved via nucleos(t)ide analog monotherapy; 3.Coinfection with hepatitis A virus (HAV), hepatitis C virus (HCV), hepatitis D virus (HDV), hepatitis E virus (HEV), or human immunodeficiency virus (HIV); 4.Severe uncontrolled systemic diseases: renal, cardiac, pulmonary, vascular, neurological, gastrointestinal, or metabolic disorders (e.g., uncontrolled hyperthyroidism, diabetic complications, adrenal diseases); immunodeficiency; active/suspected malignancy; or history of malignancy; 5.Use of interferon, corticosteroids, immunosuppressants, or chemotherapeutic agents within 6 months prior to PegIFNa therapy; 6.Current use or use within the past 6 months of corticosteroids, immunosuppressants, or chemotherapeutic agents; 7.Concurrent liver diseases (e.g., alcoholic liver disease, autoimmune liver disease; non-alcoholic fatty liver permitted); 8.Investigator-determined unsuitability for enrollment (e.g., poor compliance); 9.Extrahepatic manifestations of chronic hepatitis B; 10.Contraindications to interferon therapy: depression, thyroid dysfunction, neutrophil count <0.5×10^9/L, or platelet count <25×10?/L; 11.Pregnancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAb; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBsAg; | — |
Countries
China
Contacts
Public ContactSujun Zheng
Beijing You An Hospital, Capital Medical University
Outcome results
None listed