Chronic hepatitis B
Conditions
Interventions
Peginterferon a-2b combined with NAs in the treatment of non-cirrhotic group:NA
NAs monotherapy for non-cirrhotic group:NA
Pegylated interferon a-2b combined with NAs in the treatment of liver cirrhosis:NA
NAs monotherapy in the liver cirrhosis group:NA
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
No minimum to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntary enrollment, with the ability to understand and sign the informed consent form; 2. Age 6 months;Prior treatment with NAs;Compensated hepatitis B-related cirrhosis (as defined in the Guidelines for the Prevention and Treatment of Chronic Hepatitis B, 2022 Edition); 5. Negative pregnancy test within 24 hours before the first treatment (for women of childbearing potential); 6. No contraindications to interferon therapy.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed with hepatocellular carcinoma (HCC) or other organ/system tumors prior to treatment; 2. Contraindications to Peg IFN a-2b use (as detailed in the Guidelines for the Prevention and Treatment of Chronic Hepatitis B, 2022 Edition); 3. Peripheral blood counts: WBC 5 × ULN (upper limit of normal) or TBIL > 2 × ULN; 5. Patients scheduled for organ transplantation or those who have undergone prior organ transplantation; 6. Patients with hypersensitivity to interferon or any contraindication listed in the drug prescribing information; 7. Other conditions deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the number and percentage of cases of cirrhosis and HCC occurring in the non-cirrhosis population;The number and percentage of cases of decompensated cirrhosis and HCC occurring in the compensated cirrhosis population; | — |
Secondary
| Measure | Time frame |
|---|---|
| HBV DNA levels, HBsAg levels, and HBeAg levels per 24 weeks;Overall survival rate (OS), median survival time, median occurrence time of cirrhosis and HCC in the decompensated cirrhotic population;Overall survival rate (OS), median survival time, median occurrence time of cirrhosis and HCC in the non-cirrhotic population;The number and percentage of HBsAg seroconversion cases, the number and percentage of HBeAg seroconversion cases (for those who are HBeAg-positive) per 24 weeks; | — |
Countries
China
Contacts
Public ContactZhao Yingren
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed