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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-01

Study Completion Date

2029-04-30

Brief Summary

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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 hepatitis B patients without fibrosis or cirrhosis who have undetectable HBV DNA for more than 3 years after receiving NUC treatment can attempt to discontinue the drug. At the same time, the patient's HBsAg level will not be higher than 1000 IU/mL. The study will set up three groups, group A directly stopped nucleoside analogues, follow-up to 96 weeks; Group B received PegIFNα-2b monotherapy for 48 weeks, group C received PegIFNα-2b combined with NUC treatment for 48 weeks, group B and group C stopped all antiviral drugs after completing 48 weeks of treatment, and then followed up for 96 weeks, a total of 144 weeks of follow-up. This study aims to further optimize the design on the basis of previous clinical studies to observe whether sequential interferon or combined with NUC therapy can reduce the virological relapse rate of HBeAg-negative chronic hepatitis B patients with low HBsAg level after 96 weeks of discontinuation, and to observe the impact on the functional cure rate.

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Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Controlled Group

Directly stopped NUC, follow-up to 96 weeks

Group Type NO_INTERVENTION

No interventions assigned to this group

PegIFN alfa-2b 48 weeks

Discontinue the NUC treatment ,PegIFN alfa-2b for 48 weeks and follow up for 96 weeks

Group Type ACTIVE_COMPARATOR

PegIFN alfa-2b

Intervention Type DRUG

180 μg/ 0.5 ml ,hypodermic injection once a week

PegIFN alfa-2b and NUC 48 weeks

Discontinue the NUC treatment ,PegIFN alfa-2b and NUC for 48 weeks, then follow up for 96 weeks

Group Type EXPERIMENTAL

PegIFN alfa-2b and NUC

Intervention Type DRUG

180 μg/ 0.5 ml ,hypodermic injection once a week, NUC drugs should be used according to the instructions of each drug

Interventions

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PegIFN alfa-2b

180 μg/ 0.5 ml ,hypodermic injection once a week

Intervention Type DRUG

PegIFN alfa-2b and NUC

180 μg/ 0.5 ml ,hypodermic injection once a week, NUC drugs should be used according to the instructions of each drug

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No