Hospital Management and Quality of Life in Chronic Hepatitis B
Tests referral and treatment of hospital patients with chronic hepatitis B.
Plain-language title generated from the registry record
Registry title: Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection
Key facts
- Where
- Guangzhou and Zhuhai, ChinaSee the 3 sites
Where in China
- The Third Affiliated Hospital of Sun Yat-Sen UniversityGuangzhou, ChinaTaking people
- The Sixth Affiliated Hospital of Sun Yat-sen UniversityGuangzhou, ChinaNo longer taking part
- The Fifth Affiliated Hospital of Sun Yat-sen UniversityZhuhai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Third Affiliated Hospital, Sun Yat-Sen University
- Trial code
- NCT06966908
- Record updated
- 8 April 2026
- Original description
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.Read full original descriptionShow less
Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection
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.
Inclusion: 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.
Exclusion: HBsAg-positive patients already under regular follow-up in infectious disease/hepatology clinics; Chronic HBV patients on regular antiviral treatment; Additional exclusion criteria for the PRO sub-study:; 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.); Failure to complete all follow-up visits; Other conditions that the investigator deems inappropriate for participation; Pregnant or lactating women; Use of pegylated interferon during the study.