Clearing hepatitis b may lift the weight of stigma, study asks

NCT ID NCT07855029

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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First seen Oct 02, 2026 · Last updated Oct 02, 2026

Summary

Researchers are asking whether people who reach a functional cure for chronic hepatitis B feel less stigma and report better physical and mental health than those who are not cured or who relapse. The study enrolls about 400 adults from an existing hepatitis B cohort in China, sorted into cured, non-cured, relapse, and healthy control groups. Participants answer standardized questionnaires about stigma and wellbeing, and researchers compare scores across the groups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If the study shows that clearing the virus improves stigma and mental health, it could push clinics and policymakers to treat hepatitis B cure as a broader health goal, not just a lab result.
What could go wrong
This is an observational questionnaire study, so it can show links but not prove that a cure causes better wellbeing. People who volunteer for a cure-focused cohort may differ from other patients, and the findings may not apply everywhere.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Mar 2032

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • The Third Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, China

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