chronic hepatitis B
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily join the study, understand and willingly sign the informed consent form; 2. Age 18-60 years at screening (including 18 and 60), any gender; 3. History of HBsAg positivity for at least 6 months or other evidence indicating chronic hepatitis B (HBeAg positive or negative); 4. HBsAg positive at screening with HBsAg = 3000 IU/mL, HBeAg negative; 5. HBV DNA < 20 IU/mL or below the detection limit of the center at screening; 6. Negative pregnancy test within 24 hours before the first dose (for women of childbearing potential); participants must use effective contraception during the study; 7. No contraindications to interferon or nucleos(t)ide analog therapy, and willing to receive combined treatment with PEG-IFN and nucleos(t)ide analogs.
Exclusion criteria
Exclusion criteria: Group A (1) Pregnant or breastfeeding women, or those planning to conceive during the study period; (2) Individuals with neuropsychiatric disorders, especially a history of depression, anxiety, mania, schizophrenia, or a family history of psychiatric disorders (particularly depression or depressive tendencies); (3) Current infection with hepatitis A, C, D, E, and/or HIV; (4) Chronic liver disease caused by other reasons, such as alcoholic hepatitis, drug-induced hepatitis, autoimmune liver disease; (5) Evidence of acute severe liver injury, e.g., ALT > 10 ULN, or significantly elevated ALT accompanied by markedly elevated bilirubin; (6) Evidence of decompensated liver disease: serum total bilirubin > 2 times the upper limit of normal (ULN), serum albumin 1 ULN; (8) Kidney disease: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc.; or serum creatinine > 1 ULN at screening; (9) Neutrophil count 1:100; (12) Autoimmune diseases, including psoriasis, systemic lupus erythematosus, etc.; (13) Endocrine diseases, including thyroid diseases, diabetes, etc.; (14) Hypertension poorly controlled by prescription medication (blood pressure >= 140/90 mmHg); (15) History of severe heart disease, especially unstable or poorly controlled within the past 6 months; (16) Severe retinal disease or other serious eye conditions; (17) Other significant organic lesions or dysfunction of important organs; (18) Planning to receive organ transplantation or having undergone organ transplantation; (19) Standard treatment with interferon products within the past six months before screening; (20) Allergic to interferon, tenofovir, or drug excipients, or meeting any contraindications listed in the trial medication’s instructions; (21) Currently receiving treatment with two nucleos(t)ide analogues; (22) Participation in other interventional trial studies within the past three months before screening or other situations deemed inappropriate for enrollment by the investigator. 2.Group B (1) Pregnant or breastfeeding women, or those planning to conceive during the study period; (2) Individuals with neuropsychiatric disorders, especially a history of depression, anxiety, mania, schizophrenia, or a family history of psychiatric disorders (particularly depression or depressive tendencies); (3) Current infection with hepatitis A, C, D, E, and/or HIV; (4) Chronic liver disease caused by other reasons, such as alcoholic hepatitis, drug-induced hepatitis, or autoimmune liver disease; (5) Evidence of acute severe liver injury, such as ALT > 10 ULN, or significantly elevated ALT accompanied by markedly elevated bilirubin; (6) Evidence of decompensated liver disease: serum total bilirubin > 2 times the upper limit of normal (ULN), serum albumin 1 ULN; (8) Kidney disease: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc.; or serum creatinine > 1 ULN at screening; (9) Neutrophil count < 1.5 × 10^9/L or platelet count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MRI evaluation;Hepatitis B Serological Markers;HBV DNA;HBV pgRNA level;Liver function;Alpha-fetoprotein;Liver elastography;Liver ultrasound;Kidney function;Complete Blood Count (CBC); | — |
Countries
China
Contacts
Public ContactMingqin Lu
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed