A Study on the Pursuit of Sustained Clearance of HBsAg in Chronic Hepatitis B(CHB) Patients With Previous Interferon Treatment Using Pegylated Interferon Alpha

April 15, 2026 updated by: xieqing

A Prospective, Non-Randomized, Multicenter Study of Peginterferon Alfa for Pursuing Sustained Hepatitis B Surface Antigen(HBsAg) Clearance in Interferon-Pretreated Patients With Chronic Hepatitis B

This is a real-world, prospective, multicenter, non-randomized, controlled study. It aims to investigate the efficacy and safety of pegylated interferon α-2b (PEG IFN α-2b) monotherapy versus its combination with nucleos(t)ide analogs (NAs) regarding hepatitis B surface antigen (HBsAg) clearance in interferon-experienced patients with chronic hepatitis B (CHB). Subjects will receive either interferon-based therapy or NAs monotherapy based on their personal willingness and physicians' professional recommendations, with a uniform 48-week treatment course for all enrolled patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10000

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, China
        • Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • 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

N/A

Sampling Method

Non-Probability Sample

Study Population

Chronic hepatitis B patients who received pegylated interferon alpha for the first time and achieved a good response.

Description

Inclusion Criteria:

  • • Voluntary participation and ability to understand and provide written informed consent.

    • Age 18-65 years (inclusive), either gender.
    • Documented HBsAg positivity for at least 6 months, or other evidence confirming chronic hepatitis B (CHB).
    • Prior interferon therapy before enrollment (treatment discontinuation ≥ 3 months), with HBsAg level at the end of prior treatment reduced by ≥ 50% from baseline.
    • HBsAg ≤ 500 IU/mL at screening, and HBsAg rebound at screening not exceeding 50% of the baseline HBsAg level during the first-round interferon therapy.
    • Negative pregnancy test within 24 hours prior to the first dose (for women of childbearing potential); all subjects (male and female) must use effective contraceptive measures during the study.

Exclusion Criteria:

  • • Pregnant or lactating women, or subjects with a pregnancy plan during the study period.

    • Subjects with neuropsychiatric disorders, in particular a history of depression, anxiety, mania, schizophrenia, or a family history of psychiatric disorders (especially a history of depression or depressive tendency).
    • Concurrent active infection with hepatitis A, hepatitis C, hepatitis E and/or HIV, or chronic liver disease due to other causes (e.g., alcoholic hepatitis, drug-induced liver injury, autoimmune liver disease, etc.).
    • Evidence of acute severe liver damage: e.g., ALT > 10 × ULN, or marked ALT elevation accompanied by significant hyperbilirubinemia.
    • Evidence of decompensated liver disease: e.g., ascites, esophagogastric variceal bleeding, sepsis, hepatic encephalopathy, hepatorenal syndrome, etc.; or prior evidence of decompensated cirrhosis.
    • Evidence of hepatocellular carcinoma (HCC), or AFP > 1 × ULN.
    • Renal diseases: acute or chronic nephritis, renal insufficiency, nephrotic syndrome, etc.; or serum creatinine > 1 × ULN at screening.
    • Neutrophil count < 1.5 × 10⁹/L, platelet count < 90 × 10⁹/L, or serum phosphorus < 0.8 mmol/L during the screening period.
    • Autoimmune diseases (e.g., psoriasis, systemic lupus erythematosus, etc.), endocrine disorders (e.g., thyroid diseases, diabetes, etc.), hypertension poorly controlled by prescription medications (blood pressure ≥ 140/90 mmHg), a history of severe heart disease (especially poorly controlled within 6 months), severe retinopathy or other serious ophthalmologic diseases, or other organic lesions or dysfunction of vital organs.
    • Subjects planning to undergo or having previously undergone organ transplantation.
    • Subjects with hypersensitivity to the investigational product or its excipients, or meeting any contraindication listed in the prescribing information of the investigational product.
    • Other conditions deemed inappropriate for enrollment by the investigator

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Peginterferon α-2b based treatment group
Drug: PEG IFNα-2b monotherapy or combination therapy with NAs
Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks.If HBV DNA is below the lower limit of detection at baseline (highly sensitive assay is recommended), PEG IFNα-2b monotherapy will be administered.
NAs monotherapy group
Drug: NAs monotherapy group
Peginterferon α-2b injection, 180mcg, s.c, once a week, for 48 weeks.If HBV DNA is below the lower limit of detection at baseline (highly sensitive assay is recommended), PEG IFNα-2b monotherapy will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of subjects with undetectable HBsAg
Time Frame: Week 48
Week 48
Percentage of subjects with undetectable HBV DNA
Time Frame: Week 48
Week 48

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients with a decrease in HBV DNA from baseline
Time Frame: Week 1-48
Week 1-48
Proportion of subjects with HBV DNA below the lower limit of detection
Time Frame: Week 1-48
Week 1-48
Number of patients with a decrease in HBsAg from baseline
Time Frame: Week 1-48
Week 1-48
Proportion of HBsAg seroclearance
Time Frame: Week 1-48
Week 1-48
Proportion of HBsAg seroconversion
Time Frame: Week 1-48
Week 1-48
Proportion of HBeAg seroclearance
Time Frame: Week 1-48
Week 1-48
Proportion of HBeAg seroconversion
Time Frame: Week 1-48
Week 1-48
Serious adverse events
Time Frame: Week 1-48
Week 1-48

Collaborators and Investigators

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

Sponsor

xieqing

Investigators

  • Principal Investigator: Qing Xie, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

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 30, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 15, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Leading Study2.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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