Recruiting

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

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Study Aim

This observational study aims to measure the social-psychological perceived stigma associated with Hepatitis B Virus Infection among participants from the 'Zhufeng Project' cohort, using the Hepatitis B Virus Infection-Related Stigma Scale. It will compare total scores across three subgroups: clinical cure group, non-cured group, and relapse group.

What is being collected

Data Collection

+ other Data

+ other Data

Collected at a single point in time - Cross-sectional
Other
Who is being recruted

Blood-Borne Infections+14

+ Chronic Disease

+ Communicable Diseases

From 18 to 65 Years
+27 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: July 2026
See protocol details

Summary

Principal SponsorZhiliang Gao
Study ContactZhiliang Gao, Ph.DMore contacts
Last updated: October 2, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2026

Actual date on which the first participant was enrolled.

This study focuses on understanding the impact of a 'functional cure' for chronic hepatitis B on patients' quality of life and perceived stigma. It involves individuals from the 'Everest Project' cohort, who are divided into four groups: those who have achieved a clinical cure, those who have not, those who have experienced a relapse, and healthy individuals as a control group. The aim is to provide a comprehensive understanding of the psychological and social benefits of a clinical cure for hepatitis B, which could help in shifting the focus from a purely medical approach to a more holistic health model. This could also provide valuable insights for improving patient care and formulating public health policies to reduce stigma associated with the condition. Participants in this study will complete questionnaires, both online and offline, using internationally recognized scales. The primary outcome measured is the total score on the Hepatitis B Virus Infection-Related Stigma Scale (HBVISS). This scale quantifies the social and psychological stigma perceived by participants. The scores will be compared across three groups: those who have achieved a clinical cure, those who have not, and those who have experienced a relapse. A higher score indicates a greater perceived stigma.

Principal SponsorZhiliang Gao
Study ContactZhiliang Gao, Ph.DMore contacts
Last updated: October 2, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsChronic DiseaseCommunicable DiseasesDigestive System DiseasesDNA Virus InfectionsHepatitisHepatitis BHepatitis, ChronicHepatitis, Viral, HumanInfectionsLiver DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVirus DiseasesHepadnaviridae InfectionsDisease AttributesHepatitis B, Chronic

Criteria

22 inclusion criteria required to participate
ALT level <= upper limit of normal (ULN) at screening

Aged between 18 and 65 years old, inclusive

Alanine aminotransferase (ALT) level <= upper limit of normal (ULN) at screening

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

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5 exclusion criteria prevent from participating
Co-infection with HIV, HCV, or HDV

Other conditions deemed ineligible for participation in this study by the investigator(s)

Presence of decompensated liver cirrhosis, hepatocellular carcinoma, or other malignant tumors

Presence of other chronic diseases that severely impair quality of life (e.g., end-stage renal disease, severe heart failure, etc.)

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, ChinaOpen The Third Affiliated Hospital of Sun Yat-sen University in Google Maps
Recruiting
One Study Center