Immunomodulatory Therapy and Predictors of Clinical Cure in Chronic Hepatitis B

December 27, 2025 updated by: Bo Feng, Peking University People's Hospital

Study on Novel Immunomodulatory Therapeutic Regimens for Clinical Cure of Chronic Hepatitis B and Efficacy Prediction

Achieving clinical cure, defined as hepatitis B surface antigen (HBsAg) seroclearance, represents a major research focus and an ideal therapeutic goal for chronic hepatitis B (CHB). A significant challenge in CHB management lies in promoting clinical cure, reducing relapse, and progressing towards complete cure. Studies have found that in patients who achieve HBsAg seroclearance following peginterferon alfa (PegIFNα) therapy, the seroconversion of anti-HBs and its attainment to a certain level are crucial for minimizing relapse. Strategies to promote anti-HBs seroconversion include active immunization (hepatitis B vaccine) and passive immunization (hepatitis B immunoglobulin, HBIG). Existing literature and preliminary findings from our team suggest that hepatitis B vaccine alone is ineffective in preventing relapse after clinical cure. This project proposes a multicenter, prospective, randomized controlled study. It will enroll CHB patients who have achieved HBsAg seroclearance with PegIFNα-based therapy, with the primary endpoint being the sustained HBsAg seroclearance rate at 48 weeks. The study will compare the efficacy between a group receiving HBIG immunization and a non-immunization control group. We anticipate that passive immunization with HBIG following HBsAg seroclearance will lead to a sustained clinical cure in CHB patients. This study aims to explore novel approaches for reducing relapse after clinical cure and pursuing complete cure, identify relevant biomarkers, and establish corresponding predictive models.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
132

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Recruiting
        • Peking University People's Hospital
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 to 60 years (inclusive).
  2. Documented HBsAg and/or HBV DNA positivity for over 6 months.
  3. Achieved HBsAg seroclearance (<0.05 IU/mL) following a PegIFNα-based treatment regimen.
  4. HBeAg negative and HBV DNA <10 IU/mL.
  5. Good compliance and willingness to voluntarily sign the informed consent form.

Exclusion Criteria:

  1. Current decompensated cirrhosis or a history of decompensated cirrhosis.
  2. Individuals with spontaneous or Nucleos(t)ide analogue-induced HBsAg seroclearance.
  3. Coinfection with other viruses, such as hepatitis A, C, D, E viruses, or human immunodeficiency virus (HIV).
  4. Severe concurrent physical or mental illnesses other than hepatitis B, including uncontrolled primary renal, cardiac, pulmonary, vascular, neurological, digestive, or severe metabolic diseases (e.g., uncontrolled hyperthyroidism, severe diabetic complications, adrenal disorders), immunodeficiency diseases, or severe infections; active or suspected malignancy, or a history of malignancy.
  5. Use of corticosteroids, immunosuppressants, or chemotherapeutic agents within the 6 months prior to enrollment or at present.
  6. Concurrent other liver diseases such as alcoholic liver disease or autoimmune liver disease.
  7. Body Mass Index (BMI) > 28 kg/m².
  8. Any other condition considered by the investigator to potentially compromise patient compliance or otherwise make the patient unsuitable for participation in the study.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: control group
Experimental: HBIG immunization group
Patients with HBsAg seroclearance will receive an intramuscular injection of HBIG 400 IU upon enrollment. Based on the results of the hepatitis B serology panel follow-up, a supplemental HBIG injection will be administered promptly when necessary (i.e., when anti-HBs is negative or anti-HBs < 100 mIU/mL), with the goal of achieving anti-HBs seroconversion and maintaining its level above 100 mIU/mL.
Drug: Hepatitis B Immunoglobulin (HBIg)
Patients with HBsAg seroclearance will receive an intramuscular injection of HBIG 400 IU upon enrollment. Based on the results of the hepatitis B serology panel follow-up, a supplemental HBIG injection will be administered promptly when necessary (i.e., when anti-HBs is negative or anti-HBs < 100 mIU/mL), with the goal of achieving anti-HBs seroconversion and maintaining its level above 100 mIU/mL.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The sustained HBsAg seroclearance rate (HBsAg < 0.05 IU/mL) at 48 weeks after initial HBsAg seroclearance
Time Frame: From enrollment to 48 weeks
From enrollment to 48 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peking University People's Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202424084

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

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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