Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection

NCT06966908 | Recruiting DMC

• 1 other identifier: PL19
• Study Type: observational
• Target: 16,300
• Locations: 1 country
• Sites: 3

Brief Summary

Since 2022, the Third Affiliated Hospital of Sun Yat-sen University has initiated the "Hot Wave Project", a comprehensive hepatitis B infection prevention and management system encompassing patient education, screening, referral, treatment, and follow-up. In 2024, this system was expanded to the Sixth Affiliated Hospital and the Fifth Affiliated Hospital of Sun Yat-sen University, transitioning into a multicenter, hospital-based cohort study on hepatitis B management.The primary objective of this study is to increase the referral rate of HBsAg-positive patients in non-hepatology/non-infectious disease departments to 50%. The secondary objective is to improve the treatment rate of hepatitis B infected patients in non-hepatology/non-infectious disease departments, particularly focusing on the diagnosed but untreated (DBU) population. Furthermore, this study aims to analyze the cost-effectiveness and clinical benefits of in-hospital hepatitis B screening and management strategies.In 2025, a Patient-Reported Outcomes (PRO) sub-study was added to the project to evaluate the impact of antiviral therapy on the Health-Related Quality of Life among a cohort of treatment-naïve patients with chronic hepatitis B.

Conditions

Chronic Hepatitis B

Keywords

Chronic Hepatitis B; linkage to care; management; patient reported outcome

Outcome Measures

Primary Outcomes (2)

• Referral Rate

  Referral rate of HBsAg-positive patients in non-infectious disease departments = Number of HBsAg-positive patients referred to infectious disease departments / Total number of HBsAg-positive patients in non-infectious disease departments.

  2 weeks

• Changes in Health-Related Quality of Life assessed by the CHBQOL Scale

  Patient-Reported Outcomes (PROs) and HRQoL are evaluated using the validated, localized Chronic Hepatitis B Quality of Life Scale (CHBQOL). The CHBQOL comprises 23 items categorized into four dimensions: physical symptoms, emotional symptoms, beliefs, and social stigma. This measure will calculate the longitudinal changes in both the total CHBQOL score and its dimension-specific sub-scores before and after initiating standard antiviral therapy. The objective is to quantify the impact of antiviral treatment on the quality of life in treatment-naïve CHB patients.

  Baseline (Week 0), week 24, and week 48

Secondary Outcomes (4)

• Antiviral Treatment Rate

  2 weeks

• Incremental Cost-Effectiveness Ratio

  3 years

• Correlation Between HRQoL Changes and Clinical Responses

  Baseline (Week 0), Week 24, and Week 48

• Predictive Factors Affecting HRQoL Changes

  Baseline (Week 0), Week 24, and Week 48

Study Arms (2)

In-Hospital HBV Linkage-to-Care Cohort

This cohort consists of HBsAg-positive patients identified in non-hepatology and non-infectious disease departments across three participating medical centers from. An estimated 16,000 patients will be included in this prospective management cohort.Participants in this cohort are managed under the multidisciplinary "Hot wave Project 2.0" workflow. Positive HBsAg results are automatically captured by the hospital information system and flagged with cautionary remarks. Full-time project nurses proactively contact these patients via telephone, providing them with patient education materials, a quick medical consultation card, and encouraging them to visit the dedicated "Hepatitis B Health Clinic" within 2 weeks.

Other: Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department.

Antiviral Therapy PRO Cohort

This cohort consists of adult (≥ 18 years), treatment-naïve patients with chronic hepatitis B enrolled from the "Hot wave Project 2.0" management cohort. Eligible patients must meet the indications for antiviral treatment according to the 2022 Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B.Participants in this observational cohort will initiate standard-of-care antiviral therapy as prescribed by their physicians. Throughout the study, their Health-Related Quality of Life will be longitudinally assessed using the localized Chronic Hepatitis B Quality of Life Scale (CHBQOL). PRO assessments, alongside routine clinical parameters will be systematically collected at baseline (Week 0), and at 24 weeks and 48 weeks post-treatment. The target enrollment for this cohort is 300 participants.

Other: Assessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B.

Interventions

Assessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B. OTHER

Patients with chronic hepatitis B who meet treatment criteria and have not previously received treatment will undergo a routine clinical evaluation in a private setting under the guidance of trained staff and complete the Chronic Hepatitis B Quality of Life (CHBQOL) questionnaire prior to initiating standard antiviral therapy (baseline, Week 0). Subsequently, patients will return for scheduled follow-up visits at Weeks 24 and 48 after treatment initiation. During follow-up visits, physicians will assess liver function and virological suppression. Additionally, the CHBQOL questionnaire will be administered again to evaluate changes in patients' health-related quality of life over time, as well as to monitor medication adherence and adverse events.

Antiviral Therapy PRO Cohort

Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department. OTHER

After visiting the hospital, high-risk HBV patients are prescribed HBsAg testing by their primary physician. If HBsAg positivity is detected in patients from non-infectious disease departments, their lab reports will include a reminder to visit the Hepatitis B Health Clinic. Some primary physicians may also request an infectious disease consultation or recommend patient referral. Additionally, within two weeks, the Hepatitis B Specialist Assistant will contact the patients by phone to provide referral recommendations. Once referred to the Hepatitis B Health Clinic, physicians will conduct health education, complete liver function and virological assessments, and develop individualized treatment and follow-up plans.

In-Hospital HBV Linkage-to-Care Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HBsAg-positive patients attending non-infectious disease/hepatology departments. PRO sub-study: Adult patients who have not previously received treatment and have been diagnosed with chronic hepatitis B

You may qualify if:

• HBsAg-positive patients attending non-infectious disease/hepatology departments at three study centers.
• Age ≥ 18 years;
• Treatment-naïve HBV-infected patients;
• Meet the treatment criteria according to the "Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B" (2022 version);
• Be able to understand the study content, willing to participate, and sign the informed consent;
• Have the ability to complete questionnaires independently or with assistance.

You may not qualify if:

• HBsAg-positive patients already under regular follow-up in infectious disease/hepatology clinics.
• Chronic HBV patients on regular antiviral treatment.
• History of chronic liver diseases other than chronic HBV infection, including but not limited to: alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease, etc. Co-infection with HCV, HDV, or HIV. Presence of other severe conditions that may affect HRQoL (such as severe cardiovascular and cerebrovascular diseases, uncontrolled mental illnesses, malignant tumors, etc.);
• Pregnant or lactating women;
• Use of pegylated interferon during the study;
• Failure to complete all follow-up visits;
• Other conditions that the investigator deems inappropriate for participation.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (3)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

RECRUITING

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510655, China

COMPLETED

The Fifth Affiliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, 519000, China

COMPLETED

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liang Peng

  Third Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Zhongsi Hong

  Fifth Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

• Fangfang Wei

  Sixth Affiliated Hospital, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Peng

CONTACT

+8613533978874; pliang@mail.sysu.edu.cn

Qiumin Luo

CONTACT

+8618629634720; luoqm7@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: May 13, 2025
• Study Start: January 3, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CN (3)