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

ConditionChronic Hepatitis B
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorZhiliang Gao

About this trial

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

This trial accepts healthy volunteers

Qualifiers

Have participated in the "Zhufeng Project" with complete clinical data available.

Aged between 18 and 65 years old, inclusive.

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;

Disqualifiers

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.).

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Observation-based data collection via patient-reported questionnaires

    Other intervention

    No investigational intervention is assigned. Participants are categorized by their clinical hepatitis B status; patient-reported outcome questionnaires are administered for study assessments.

Treatment groups

400 Participants
are divided into 4 treatment groups
Group A: Clinical cure group1 intervention
Group B: Non-cured group1 intervention
Group C: Relapse group1 intervention
Group D: Healthy control group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline (cross-sectional assessment at study enrollment)

Secondary outcomes

1

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.

Time frame
Baseline
2

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.

Time frame
Baseline
3

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.

Time frame
Baseline
4

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhiliang Gao

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Sponsor institution

Source ClinicalTrials.gov
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