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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• HBsAg-positive patients attending non-infectious disease/hepatology departments at three study centers.

⁃ Additional inclusion criteria for the PRO sub-study:

• 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.

Locations
Other Locations
China
The Sixth Affiliated Hospital of Sun Yat-sen University
COMPLETED
Guangzhou
The Third Affiliated Hospital of Sun Yat-sen University
RECRUITING
Guangzhou
The Fifth Affiliated Hospital of Sun Yat-sen University
COMPLETED
Zhuhai
Contact Information
Primary
Liang Peng
pliang@mail.sysu.edu.cn
+8613533978874
Backup
Qiumin Luo
luoqm7@mail.sysu.edu.cn
+8618629634720
Time Frame
Start Date: 2025-01-03
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 16300
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Third Affiliated Hospital, Sun Yat-Sen University

This content was sourced from clinicaltrials.gov