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Massive hospital study aims to boost hepatitis b diagnosis and treatment

NCT ID NCT06966908

Disease control Sponsor: Third Affiliated Hospital, Sun Yat-Sen University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study involves over 16,000 people with chronic hepatitis B across three hospitals. The goal is to increase the number of patients referred to liver specialists and started on antiviral treatment. Researchers will also track how antiviral therapy affects patients' quality of life over time.

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 16,300 people

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

Started

Jan 2025

Expected to finish

Dec 2027

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

HBsAg-positive patients attending non-infectious disease/hepatology departments. PRO sub-study: Adult patients who have not previously received treatment and have been diagnosed with chronic hepatitis B

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * HBsAg-positive patients attending non-infectious disease/hepatology departments at three study centers. Additional inclusion criteria for the PRO sub-study: * Age ≥ 18 years; * Treatment-naïve HBV-infected patients; * Meet the treatment criteria according to the "Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B" (2022 version); * Be able to understand the study content, willing to participate, and sign the informed consent; * Have the ability to complete questionnaires independently or with assistance. Exclusion Criteria: * HBsAg-positive patients already under regular follow-up in infectious disease/hepatology clinics. * Chronic HBV patients on regular antiviral treatment. Additional exclusion criteria for the PRO sub-study: * History of chronic liver diseases other than chronic HBV infection, including but not limited to: alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease, etc. Co-infection with HCV, HDV, or HIV. Presence of other severe conditions that may affect HRQoL (such as severe cardiovascular and cerebrovascular diseases, uncontrolled mental illnesses, malignant tumors, etc.); * Pregnant or lactating women; * Use of pegylated interferon during the study; * Failure to complete all follow-up visits; * Other conditions that the investigator deems inappropriate for participation.

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Conditions

The condition(s) this trial relates to.

chronic hepatitis B virus infection hepatitis B virus infection

As listed by the trial registrant

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

Chronic hepatitis B

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    COMPLETED

    Zhuhai, Guangdong, 519000, China

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    COMPLETED

    Guangzhou, Guangdong, 510655, China

  • The Third Affiliated Hospital of Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510630, China

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