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NCT07855029
Impact of Functional Cure of Chronic Hepatitis B on Patient-Reported Outcomes (PROs)
Conditions: Chronic Hepatitis B
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Enrollment: 400
Sponsor: Zhiliang Gao
Location: The Third Affiliated Hospital of Sun Yat-sen University Guangzhou
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. 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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07855029). StuddyBuddy aggregates publicly available trial information.