Chronic Hepatitis B
Conditions
Interventions
Treatment group:Receive 48-week treatment with PEG IFNa-2b combined with NAs. PEG IFNa-2b is administered subcutaneously once weekly at a dose of 135 µg per injection.
Sponsors
Deyang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily participate in this study and sign the informed consent form. 2.Aged 18 to 60 years. 3.Normal liver biochemistry indices. 4.HBsAg <= 500 IU/mL, and HBsAg positivity for more than 6 months. 5.HBV DNA < 20 IU/mL or below the lower limit of detection. 6.HBeAg negative. 7.No use of interferon or other immunomodulators within 6 months before treatment. 8.The patient agrees to adopt appropriate contraceptive measures (including at least one barrier contraceptive method) during the entire trial.
Exclusion criteria
Exclusion criteria: 1.Patients with acute or chronic liver diseases not caused by HBV infection. 2.Patients with contraindications to liver biopsy. 3.Positive for hepatitis C antibody or HIV antigen/antibody. 4.Patients who have used liver-protecting drugs within 1 month before enrollment (including but not limited to ademetionine, 5.diammonium glycyrrhizinate, ursodeoxycholic acid, etc.). Patients who have progressed to cirrhosis or liver cancer. 6.Patients with severe or uncontrolled underlying diseases: such as infections, cardiovascular and cerebrovascular accidents, diabetes, epilepsy, rheumatoid arthritis, malignant tumors, etc. 7.Pregnant or lactating women. 8.Patients with suspected or confirmed history of alcohol or drug abuse. 9.Patients who have participated in or are currently participating in other hepatitis drug trials within 6 months. 10.Subjects whom the investigator deems to have other factors unsuitable for participating in this trial.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| HBsAg seroclearance rate;Incidence of adverse clinical outcomes (including cirrhosis and related complications, liver failure, HCC); | — |
Primary
| Measure | Time frame |
|---|---|
| Changes in intrahepatic cccDNA compared with baseline;Changes in intrahepatic integrated HBV DNA compared with baseline;Changes in intrahepatic HBsAg compared with baseline;Changes in intrahepatic CD4+ compared with baseline;Changes in intrahepatic CD8+ compared with baseline;Changes in intrahepatic NK compared with baseline;Changes in peripheral blood HBsAg compared with baseline;Changes in peripheral blood HBV RNA compared with baseline; | — |
Countries
China
Contacts
Public ContactYang Jiahong
Deyang Cancer Hospital
Outcome results
None listed