Impact of Functional Cure of Chronic Hepatitis B on Patient-Reported Outcomes (PROs)

September 28, 2026 updated by: Zhiliang Gao

Single-Center Cohort Study on the Impact of Functional Cure of Chronic Hepatitis B on Patient-Reported Outcomes (PROs)

This single-center comparative cross-sectional study includes a prospective longitudinal follow-up cohort. At least 400 subjects from the "Everest Project" cohort will be enrolled into four groups: clinical-cure, non-cure, relapse, and healthy control. Data will be collected via online/offline questionnaires with internationally-standardized scales. This study aims to first systematically characterize the psychosocial value of chronic hepatitis B clinical cure, advance the shift from biomedical to biopsychosocial holistic health model, and provide scientific evidence for patient-management optimization and stigma-reduction public-health policy-making.

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.
Observational

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.
400

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
      • Guangzhou, China
        • Recruiting
        • The Third Affiliated Hospital of Sun Yat-sen University
        • Contact:
          • Zhiliang Gao

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This observational cohort study enrolls 400 participants aged 18-65 years. Participants are recruited from the Zhufeng Project chronic hepatitis B cohort and frequency-matched healthy volunteers. Four groups are defined based on hepatitis B disease status: functional cure group, non-cured group, relapse group, and healthy control group. All participants provide written informed consent. Individuals with decompensated cirrhosis, HCC, other malignancies, HIV/HCV/HDV co-infection, severe uncontrolled psychiatric illness or severe comorbidities affecting quality of life are excluded.

Description

Inclusion Criteria:

  • Have participated in the "Zhufeng Project" with complete clinical data available.
  • Aged between 18 and 65 years old, inclusive.
  • Meet one of the following group-specific criteria:

Group 1: Functional Cure Group：

  • Subjects in the functional cure group are individuals with a well-documented history of chronic hepatitis B (HBsAg-positive for ≥6 months) who have achieved functional cure following antiviral therapy.
  • Inclusion criteria for this group:
  • All antiviral therapies have been discontinued, and the off-treatment follow-up period from treatment discontinuation to the screening visit is no less than 24 weeks;
  • Sustained post-treatment response during this period, operationally defined as confirmed HBsAg negativity (quantitative assay <0.05 IU/mL) at or after Week 24 post-treatment discontinuation, plus persistently undetectable HBV DNA (<10 IU/mL) by high-sensitivity PCR assay from treatment cessation through screening;
  • Alanine aminotransferase (ALT) level ≤ upper limit of normal (ULN) at screening.

Group 2: Non-cured Group (active comparator group for this study)：

  • The non-cured group serves as the active comparator and consists of participants with chronic hepatitis B receiving long-term effective antiviral treatment.
  • Eligibility criteria:
  • Receiving stable monotherapy with nucleos(t)ide analogs (NAs), with a total treatment duration of no less than 52 weeks. "Stable treatment" is defined as no regimen modification within the 24 weeks prior to screening;
  • Sustained virological suppression: documented HBV DNA below the lower limit of detection (<20 IU/mL) on at least two occasions (interval >12 weeks) within the 24 weeks before screening;
  • Persistently positive HBsAg (>0.05 IU/mL) at screening;
  • ALT level ≤ upper limit of normal (ULN) at screening.

Group 3: Healthy Control Group：

  • The healthy control group provides normative baseline data for quality-of-life assessments. Eligible participants must be seronegative for all HBV serological markers (i.e., negative for HBsAg, anti-HBc, and HBV DNA), and have no known history of acute or chronic liver diseases.
  • Individuals with malignancy, severe cardiovascular or cerebrovascular diseases, psychiatric disorders, or other major systemic diseases that may independently affect quality of life are excluded. To minimize confounding from demographic variables, this group will be frequency-matched to the prior two groups by age (±5 years), sex, and educational level. All enrolled subjects must have ALT levels within the normal range at screening.

Group 4: Relapse Group：

  • Participants who previously fulfilled all eligibility criteria of the Functional Cure Group but developed virological relapse during off-treatment follow-up, defined as reversion from HBsAg-negative to HBsAg-positive status, and/or HBV DNA becoming detectable after being below the limit of detection.
  • Provide written informed consent for study participation.

Exclusion Criteria:

  • Presence of decompensated liver cirrhosis, hepatocellular carcinoma, or other malignant tumors.
  • Co-infection with HIV, HCV, or HDV.
  • Suffering from severe uncontrolled psychiatric disorders (e.g., schizophrenia, major depressive episode) or dementia.
  • Presence of other chronic diseases that severely impair quality of life (e.g., end-stage renal disease, severe heart failure, etc.).
  • Other conditions deemed ineligible for participation in this study by the investigator(s).

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

  • Observational Models: COHORT
  • Time Perspectives: CROSS_SECTIONAL

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Healthy control group
Other: Observation-based data collection via patient-reported questionnaires

No investigational intervention is assigned. Participants are categorized by their clinical hepatitis B status; patient-reported outcome questionnaires are administered for study assessments.
Clinical cure group
Other: Observation-based data collection via patient-reported questionnaires

No investigational intervention is assigned. Participants are categorized by their clinical hepatitis B status; patient-reported outcome questionnaires are administered for study assessments.
Non-cured group
Other: Observation-based data collection via patient-reported questionnaires

No investigational intervention is assigned. Participants are categorized by their clinical hepatitis B status; patient-reported outcome questionnaires are administered for study assessments.
Relapse group
Other: Observation-based data collection via patient-reported questionnaires

No investigational intervention is assigned. Participants are categorized by their clinical hepatitis B status; patient-reported outcome questionnaires are administered for study assessments.

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
Measure Description
Time Frame
Hepatitis B Virus Infection-Related Stigma Scale (HBVISS) total score
Time Frame: Baseline (cross-sectional assessment at study enrollment)

Social-psychological perceived stigma among participants from the "Zhufeng Project" cohort will be quantified using the HBVISS. Total scores will be compared across three subgroups: clinical cure group, non-cured group, and relapse group. Higher scores indicate higher perceived stigma.
Baseline (cross-sectional assessment at study enrollment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
PROMIS® GH-10 Global Physical Health (GPH) T-score
Time Frame: Baseline

T-score for global physical health, assessed using the PROMIS GH-10 instrument. Scores are compared across the four groups: clinical cure group, non-cured group, relapse group, and healthy control group.
Baseline
PROMIS® GH-10 Global Mental Health (GMH) T-score
Time Frame: Baseline

T-score for global mental health, assessed using the PROMIS GH-10 instrument. Scores are compared across the four groups: clinical cure group, non-cured group, relapse group, and healthy control group.
Baseline
Fear of Progression Questionnaire-Short Form (FoP-Q-SF) total score
Time Frame: Baseline

Total score of FoP-Q-SF, evaluating fear of disease progression among participants in non-cured group and relapse group.
Baseline
Brief Illness Perception Questionnaire (B-IPQ) domain-specific scores
Time Frame: Baseline

Domain-level scores from B-IPQ for assessment of illness perception patterns in non-cured and relapse participants.
Baseline

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.
Zhiliang Gao

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University

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 (Actual)

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.
July 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.
March 31, 2029

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.
March 31, 2032

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).
September 21, 2026

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.
September 28, 2026

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.
October 2, 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.
October 2, 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.
September 28, 2026

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.
September 1, 2026

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.
  • II2026-121-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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