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

March 21, 2025 updated by: Jiming Zhang, Huashan Hospital

A Prospective, Open-Label, Randomized, Controlled, Multicenter Clinical Study of Pegylated Interferon Alfa-2b in Reducing Relapse Rates After Nucleos(t)ide Analogue Withdrawal in HBeAg-Negative Chronic Hepatitis B Patients with Low-Level HBsAg

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Huashan Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Controlled Group
Directly stopped NUC, follow-up to 96 weeks
Active Comparator: PegIFN alfa-2b 48 weeks
Discontinue the NUC treatment ,PegIFN alfa-2b for 48 weeks and follow up for 96 weeks
Drug: PegIFN alfa-2b
180 μg/ 0.5 ml ,hypodermic injection once a week
Experimental: 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who relapse
Time Frame: 96 weeks after stopping NAs
the cumulative virological relapse rate (HBV DNA>2000 IU/ml on 2 separate occasions 1 months apart) during the research period.
96 weeks after stopping NAs

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who relapse
Time Frame: 72 weeks after stopping all antivirals
The total number of relapse (HBV DNA>2000 IU/ml on 2 separate occasions 1 months apart) during the research period.
72 weeks after stopping all antivirals
Number of participants who relapse Clinically
Time Frame: 72 weeks and 96 weeks after stopping all antivirals
72 weeks and 96 weeks after stopping all antivirals
Number of participants who achieve HBsAg clearance and HBsAg seroconversion
Time Frame: 96 weeks after stopping all antivirals
96 weeks after stopping all antivirals
Number of participants who restart treatment
Time Frame: 96 weeks after stopping all antivirals
Patients with virological relapse may be retreated according to the following criteria: 1) ALT >10×ULN, 2)ALT >5×ULN and total bilirubin >2 mg/dl, 3)ALT >3×ULN and HBV DNA >100,000 IU/ml, 4) ALT >ULN and HBV DNA >2,000 IU/ml for more than 3 months; 5) PT increases by more than 2s, while ALT >5×ULN.
96 weeks after stopping all antivirals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Principal Investigator Jiming Zhang, M.D., Huashan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

March 21, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 28, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEASE2.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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