Chronic Hepatitis B
Conditions
Interventions
Maternal group A1 on antiviral treatment during pregnancy:None
Maternal group A2 on antiviral treatment during pregnancy: Peg-IFNa-2b treatment
Maternal group B1 on non-antiviral treatment during pregnancy:none
Maternal group B2 on non-antiviral treatment during pregnancy: Peg-IFNa-2b treatment
Sponsors
First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
Female
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Chronic HBV-infected postpartum women aged 20 = age = 45 years; (2) 6-18 months after delivery; (3) HBV DNA =20,000 IU/mL at screening; (4) HBsAg = 5000IU/mL or a decrease in HBsAg of > 0.3logIU/mL from the last test at screening; Volunteer to participate in the study, have a negative pregnancy test, and agree to contraception during treatment and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Mothers who are breastfeeding; (2) Mothers with a planned pregnancy during the study period; (3) Co-infection with hepatitis A, C, D, E and/or current HIV infection; (4) Evidence of acute severe liver damage: e.g., ALT = 10 ULN, or markedly elevated ALT with markedly elevated bilirubin; (5) Those with evidence of decompensated liver disease or previous evidence of decompensated cirrhosis; (6) Those with evidence of hepatocellular carcinoma; (7) Screening neutrophil count 1:100 during the screening period; (9) Patients with retinopathy or other serious ophthalmic diseases during the screening period; (10) Patients with neuropsychiatric disorders, especially depression, anxiety, mania, schizophrenia and other psychiatric disorders history or family history of psychiatric disorders; (11) Patients with endocrine system diseases (e.g., thyroid disease, diabetes mellitus); (12) Severe renal, cardiovascular, pulmonary, or immune system disorders; (13) Circumstances deemed unsuitable for this study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg clearance rate and serological conversion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of Postpartum Use of Peg-IFN alpha-2b;Dynamic changes in HBeAg clearance rate, serological conversion rate, and titer;Decrease in HBsAg titer compared to baseline;Decrease in HBV DNA titer compared to baseline and the proportion of undetectable subjects; | — |
Countries
China
Contacts
Public ContactTianyan Chen
First Affiliated Hospital of Xi 'an Jiaotong University
Outcome results
None listed