Pegylated Interferon Alfa-2b in Reducing Relapse Rates After Nucleos(t)ide Analogue Withdrawal in HBeAg-negative CHB Patients with Low Level HBsAg

Launched by HUASHAN HOSPITAL · Mar 21, 2025

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ClinConnect Summary

This clinical trial is investigating how effective a medication called Pegylated Interferon Alfa-2b is in preventing the return of the hepatitis B virus in patients who have been off their antiviral medication for a while. Specifically, it focuses on patients with chronic hepatitis B who are HBeAg-negative (a type of virus marker) and have low levels of a surface antigen called HBsAg. Eligible participants are typically between 18 and 65 years old, have been free of the virus for over three years after treatment, and have certain health conditions that make them suitable for the study.

Participants will be divided into three groups to see different treatment effects: one group will stop their antiviral medication entirely, another will receive Pegylated Interferon alone, and the last group will have Pegylated Interferon along with continued antiviral treatment. After 48 weeks of treatment, all groups will be monitored for another 96 weeks to see if the virus comes back. The goal is to find out if these treatment approaches can help reduce the chances of the virus returning and improve the overall chance of achieving a functional cure for hepatitis B. If you're interested in this study, it's important to know that it is not yet recruiting participants, and you'll need to meet specific health criteria to participate.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Aged between 18 and 65 (inclusive), regardless of gender;
• • 2. Fibroscan ≤ 7.4kpa;
• • 3. HBeAg-negative CHB patients: HBsAg positive, HBeAg negative, HBsAb negative and HBeAb positive before receiving NUC treatment and during screening in this study;
• • 4. HBeAg-negative chronic hepatitis B patients without liver cirrhosis who have been viral-negative for more than 3 years after receiving NUC treatment, and they meet the 2017 EASL guideline discontinuation standard (HBV DNA is lower than the lower limit of detection, that is, \<20 IU/ml);
• • 5. HBsAg≤1000 IU/ml;
• • 6. Have the intention to stop taking the drug, and sign a written informed consent.
• Exclusion Criteria:
• • 1. HBsAb positive during screening;
• • 2. Patients with hepatitis B cirrhosis in the compensatory and decompensated stage: patients with a clear history of cirrhosis (imaging or histological evidence) or Child-Pugh score ≥5 before NUC treatment, or complications of cirrhosis in the decompensated stage such as ascites, hepatic encephalopathy, esophageal variceal hemorrhage, etc.;
• • 3. Patients who are allergic to alpha interferon and its drug ingredients, and the researchers judge that alpha interferon is not suitable for patients;
• • 4. Received immunomodulators (including interferon, etc.) within 1 year before screening;
• • 5. Combined with HAV, HCV, HDV, HEV, HIV infection, alcoholic liver disease, genetic metabolic liver disease, drug liver disease, non-alcoholic fatty liver disease and other chronic liver diseases;
• • 6. Combined with autoimmune diseases, including autoimmune liver disease, psoriasis, etc.
• • 7. Patients with primary liver cancer or screening with AFP greater than 100 ng/ml and imaging findings indicating the possibility of malignant liver occupation; Or AFP greater than 100 ng/ml for 3 months;
• • 8. Neutrophil count \< 1.5 x 109 cells /L or platelet count \< 90 x 109 cells /L;
• • 9. Creatinine is 1.5 times higher than the upper limit of normal;
• • 10. Patients with other malignant tumors (excluding cured patients);
• • 11. Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs;
• • 12. Patients with severe neurological and psychiatric disorders (such as epilepsy, depression, mania, seizures, schizophrenia, etc.);
• • 13. Control unstable diabetes, hypertension, thyroid disease, etc.;
• • 14. Pregnant and lactating women or patients who had pregnancy plans during the study period and did not want to use contraception;
• • 15. Participate in other clinical investigators;
• • 16. Patients who were not considered suitable for participation in this study by the investigators.