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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorThird Affiliated Hospital, Sun Yat-Sen University

About this trial

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 criteria

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department.
  • Assessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B.

Treatment groups

16,300 Participants
are divided into 2 treatment groups