Chronic hepatitis B
Conditions
Interventions
Group 1:Combined treatment
Group 2:Single drug
Sponsors
The Second Hospital of Nanjing
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. HBV DNA positive before pregnancy; 2. Accepting or not receiving standard antiviral therapy from 24w~32w to 3 months postpartum; 3. Postpartum HBsAg=4 weeks; 10. Willing to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1) Intrahepatic cholestasis, fatty liver, hyperthyroidism during pregnancy; 2) There is a serious obstetric complication; 3) Anti-HAV IgM, HCV RNA or anti-HCV, anti-HDV, anti-HEV or anti-HIV test results were positive at screening; 4) alpha-fetoprotein is greater than 100 ng/mL when screening; or alpha-fetoprotein does not remain stable for 3 months before the test and/or liver imaging examination indicates liver tumors; 5) Liver histology suggests a G/S score greater than 3, or evidence of decompensated liver disease (Child-Pugh score >=5). Child-Pugh >=5 means that if one of the following is met, the patient will be excluded: Serum albumin =3 seconds; serum bilirubin >34umol/L; Have a history of hepatic encephalopathy; History of esophageal varices bleeding; Ascites; 6) Neutrophil count <1.5x10^9 cells/L or platelet count <90x10^9 cells/L; 7) A serious history of mental illness, especially depression. Severe mental illness is defined as major depression or mental illness, suicide attempt, hospitalization for mental illness, or loss of ability for a period of time due to mental illness; 8) History of immune-mediated disease (eg inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis) or The level of autoimmune antibodies is abnormally elevated; 9) Patients with serious diseases such as heart, lung, kidney, brain and blood; 10) creatinine is 1.5 times higher than the upper limit of normal; 11) a history of severe epilepsy or currently being treated with antiepileptic drugs; 12) History of any organ transplant and existing functional grafts (except corneal or hair transplants); 13) Control unstable diabetes, hypertension, thyroid disease, etc., history of severe retinopathy or other evidence of retinopathy; 14) A history of serious illness or other evidence of a serious illness or any other disease makes the investigator feel that the patient is not suitable for the trial; 15) For those who are allergic to alpha interferon and its pharmaceutical ingredients, the investigator judges patients who are not suitable for the use of alpha interferon (previously poor response to interferon application); 16) Patients considered by the investigator to be unfit for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg negative rate; | — |
Countries
China
Contacts
Public ContactHan Guorong
The Second Hospital of Nanjing
Outcome results
None listed