Status:
NOT_YET_RECRUITING
Pegylated Interferon Alfa-2b in Reducing Relapse Rates After Nucleos(t)ide Analogue Withdrawal in HBeAg-negative CHB Patients with Low Level HBsAg
Lead Sponsor:
Huashan Hospital
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
All enrolled patients must meet the European Guidelines for the Prevention and Treatment of Chronic Hepatitis B (EASL, 2017) recommended discontinuation criteria, that is, HBeAg-negative chronic hepat...
Eligibility Criteria
Inclusion
- Aged between 18 and 65 (inclusive), regardless of gender;
- Fibroscan ≤ 7.4kpa;
- HBeAg-negative CHB patients: HBsAg positive, HBeAg negative, HBsAb negative and HBeAb positive before receiving NUC treatment and during screening in this study;
- 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);
- HBsAg≤1000 IU/ml;
- Have the intention to stop taking the drug, and sign a written informed consent.
Exclusion
- HBsAb positive during screening;
- 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.;
- Patients who are allergic to alpha interferon and its drug ingredients, and the researchers judge that alpha interferon is not suitable for patients;
- Received immunomodulators (including interferon, etc.) within 1 year before screening;
- 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;
- Combined with autoimmune diseases, including autoimmune liver disease, psoriasis, etc.
- 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;
- Neutrophil count \< 1.5 x 109 cells /L or platelet count \< 90 x 109 cells /L;
- Creatinine is 1.5 times higher than the upper limit of normal;
- Patients with other malignant tumors (excluding cured patients);
- Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs;
- Patients with severe neurological and psychiatric disorders (such as epilepsy, depression, mania, seizures, schizophrenia, etc.);
- Control unstable diabetes, hypertension, thyroid disease, etc.;
- Pregnant and lactating women or patients who had pregnancy plans during the study period and did not want to use contraception;
- Participate in other clinical investigators;
- Patients who were not considered suitable for participation in this study by the investigators.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT06900166
Start Date
April 1 2025
End Date
April 1 2029
Last Update
March 28 2025
Active Locations (1)
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1
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200040