Actively Recruiting
Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection
Led by Third Affiliated Hospital, Sun Yat-Sen University · Updated on 2026-04-08
16300
Participants Needed
3
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HBsAg-positive patients attending non-infectious disease or hepatology departments at three study centers
- For the PRO sub-study: age 18 years or older
- Treatment-nafve hepatitis B virus-infected patients
- Meet treatment criteria according to the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 version)
- Able to understand the study and willing to participate with signed informed consent
- Able to complete questionnaires independently or with assistance
You will not qualify if you...
- HBsAg-positive patients already under regular follow-up in infectious disease or hepatology clinics
- Chronic hepatitis B patients on regular antiviral treatment
- History of chronic liver diseases other than chronic hepatitis B, including alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease
- Co-infection with HCV, HDV, or HIV
- Presence of severe conditions affecting quality of life, such as severe cardiovascular and cerebrovascular diseases, uncontrolled mental illness, or malignant tumors
- Pregnant or lactating women
- Use of pegylated interferon during the study
- Failure to complete all follow-up visits
- Other conditions deemed inappropriate for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
The Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510630
Actively Recruiting
2
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China, 510655
Completed
3
The Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 519000
Completed
Research Team
L
Liang Peng
CONTACT
Q
Qiumin Luo
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here