Chronic Hepatitis BNCT07855029
Impact of Functional Cure of Chronic Hepatitis B on Patient-Reported Outcomes (PROs)
An observational study of Chronic Hepatitis B, run by Zhiliang Gao at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- Observation-based data collection via patient-reported questionnaires
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 31 Mar 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
- 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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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou
Zhiliang Gao
About this study
Official title: 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.
- Conditions
- Chronic Hepatitis B
- Being tested
- Observation-based data collection via patient-reported questionnaires
- Keywords
- Chronic Hepatitis B
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation-based data collection via patient-reported questionnairesOther
No investigational intervention is assigned. Participants are categorized by their clinical hepatitis B status; patient-reported outcome questionnaires are administered for study assessments.
| Study group | Role | What they receive |
|---|---|---|
| Clinical cure group | Not described Receives: Other: Observation-based data collection via patient-reported questionnaires | |
| Non-cured group | Not described Receives: Other: Observation-based data collection via patient-reported questionnaires | |
| Relapse group | Not described Receives: Other: Observation-based data collection via patient-reported questionnaires | |
| Healthy control group | Not described Receives: Other: Observation-based data collection via patient-reported questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hepatitis B Virus Infection-Related Stigma Scale (HBVISS) total score
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.
Measured: Baseline (cross-sectional assessment at study enrollment)
Secondary outcomes (4)
PROMIS® GH-10 Global Physical Health (GPH) T-score
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.
Measured: Baseline
PROMIS® GH-10 Global Mental Health (GMH) T-score
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.
Measured: Baseline
Fear of Progression Questionnaire-Short Form (FoP-Q-SF) total score
Total score of FoP-Q-SF, evaluating fear of disease progression among participants in non-cured group and relapse group.
Measured: Baseline
Brief Illness Perception Questionnaire (B-IPQ) domain-specific scores
Domain-level scores from B-IPQ for assessment of illness perception patterns in non-cured and relapse participants.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Jul 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Zhiliang Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Zhiliang Gao, Principal investigator, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855029
- Sponsor's protocol ID
- II2026-121-01
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No