Compares how chronic hepatitis B affects patients' reported well-being using questionnaires
Compares questionnaire answers from adults with chronic hepatitis B and healthy adults.
Plain-language title generated from the registry record
Registry title: Impact of Functional Cure of Chronic Hepatitis B on Patient-Reported Outcomes (PROs)
Key facts
- Where
- Guangzhou, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic hepatitis B who took part in the Zhufeng Project, plus healthy controls. They answer questionnaires on quality of life.
- Age
- 18 to 65 years
- Sex
- All sexes can join.
- Disease stage
- Four groups: functional cure (HBsAg negative at least 24 weeks after stopping antiviral treatment), non-cured on stable antiviral treatment, relapse after functional cure, and healthy controls. ALT must be at or below the upper limit of normal.
- Earlier treatment
- Cure group: all antiviral treatment stopped, off treatment for at least 24 weeks. Non-cured group: stable nucleos(t)ide analog treatment for at least 52 weeks, with no change in the 24 weeks before screening.
- Biomarker or test result
- Cure group: HBsAg below 0.05 IU/mL and HBV DNA below 10 IU/mL. Non-cured group: HBsAg above 0.05 IU/mL and HBV DNA below 20 IU/mL. Healthy controls: negative for HBsAg, anti-HBc and HBV DNA.
Main reasons for not taking part
- Decompensated liver cirrhosis, liver cancer or other cancer
- Co-infection with HIV, HCV or HDV
- Severe uncontrolled psychiatric disorder or dementia
- Other chronic disease that severely lowers quality of life, such as end-stage renal disease or severe heart failure
- Other conditions that the investigators judge to rule out joining
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07855029, who can take part
Where in China
- The Third Affiliated Hospital of Sun Yat-Sen UniversityGuangzhou, ChinaContact: Zhiliang GaoTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Zhiliang Gao
- Trial code
- NCT07855029
- Record updated
- 2 October 2026
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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).