NCT06966908Recruiting
Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 16300 (estimated)
- First submitted
- 18 Apr 2025
- Start date
- 3 Jan 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Diseases
- Hepatitis B
- NCT number
- NCT06966908
What you commit to
- Study type: Observational
- Planned participants: 16300
- From 3 Jan 2025 to the primary completion date, 30 Jun 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Pregnant or lactating women;
- Use of pegylated interferon during the study;
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Affiliated Hospital of Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Sixth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Completed |
| The Fifth Affiliated Hospital of Sun Yat-sen University Coordinator of this site? Confirm its status | Zhuhai | China | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.