Chronic hepatitis B virus (HBV) infection
Conditions
Interventions
Group 1:Peg-IFN alone or NAs + Peg-IFN
Group 2:treated with NAS alone or without medication
Sponsors
The First Affiliated Hospital of Army Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. NAs treatment during pregnancy, continued medication after delivery, HBsAg <= 3000 IU/mL at follow-up; 2. Patients who received NAs therapy during pregnancy and stopped taking medicine after delivery, or did not receive NAs blocking therapy during pregnancy, and had HBsAg <= 3000 IU/mL and normal liver function at postpartum follow-up; 3. Patients who received NAs therapy during pregnancy and stopped the drug after delivery, or did not receive NAs blocking therapy during pregnancy, with HBsAg <= 3000 IU/mL and hepatitis recurrence (2xULN < ALT < 10xULN) and DNA measurable at postpartum follow-up; 4. Color ultrasound did not indicate cirrhosis; 5. Aged 18 to 45 years, including 18 and 45; 6. Urine or serum pregnancy test was negative within 24 hours before the first medication; 7. No childbearing intention within two years, and in the non-lactation period; 8. Be willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Gestational cholestasis, acute fatty liver of pregnancy, hyperthyroidism; 2. Severe obstetric complications; 3. Positive for anti-HAV IgM, HCV RNA or anti-HCV, anti-HDV, anti-HEV or anti-HIV at screening; 4. Alpha-fetoprotein (APF) was greater than 100 ng/mL; Or the APF does not remain stable within 3 months prior to the trial and/or the liver imaging findings suggest liver tumors; 5. Histological examination of the liver indicated a G/S score greater than 3 or evidence of decompensated liver disease (Child-Pugh score >= 5); 6. Neutrophil count < 1.5x10^9 cells /L or platelet count < 90x10^9 cells /L; 7. History of severe mental illness, especially depression. Severe psychosis is defined as severe depression or psychosis, suicide attempts, hospitalization due to psychosis, or a period of incapacity due to psychosis; 8. A history of immune-mediated diseases (such as inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis) or abnormally elevated levels of autoimmune antibodies; 9. Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs; 10. Creatinine 1.5 times higher than the upper limit of normal; 11. History of severe epilepsy or current use of antiepileptic drugs; 12. Any history of organ transplantation and existing functional grafts (other than cornea or hair grafts); 13. Patients with unstable control of diabetes, hypertension, thyroid disease, etc., with a history of severe retinal disease or with other evidence of retinopathy; 14. A history of serious illness or other evidence of a serious illness or any other medical condition makes the investigator consider the patient unfit to participate in the trial; 15. Patients who are allergic to IFN-a and its drug components are judged not suitable for IFN-a use by the researchers (previous poor response to IFN-a use); 16. Patients were treated with Peg-IFN drugs within 4 weeks before entering the study; 17. Patients considered by the researchers to be unsuitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBsAg negative rate at the end of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBsAg and HBeAg negative conversion rate and seroconversion rate at the end of treatment and follow-up;HBsAg decreased >=1 lg IU/ml at 24 weeks of treatment;Sustained virological response rate;Safety; | — |
Countries
China
Contacts
Public ContactJiang Li
The First Affiliated Hospital of Army Medical University
Outcome results
None listed