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Recruiting 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 \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07855029). StuddyBuddy aggregates publicly available trial information.