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

Recruiting · NCT06966908 · Observational (researchers observe without assigning treatment) · Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University

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Hepatitis B

Interventions studied

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

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.

Who can take part

Age range

No age limits stated

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Not specified

Study type

Observational (researchers observe without assigning treatment)

Inclusion criteria

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 criteria

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.);
Pregnant or lactating women;
Use of pegylated interferon during the study;
Failure to complete all follow-up visits;
Other conditions that the investigator deems inappropriate for participation.

Where it is running

3 locations listed.

The Third Affiliated Hospital of Sun Yat-sen University - Guangzhou, Guangdong, China
The Sixth Affiliated Hospital of Sun Yat-sen University - Guangzhou, Guangdong, China
The Fifth Affiliated Hospital of Sun Yat-sen University - Zhuhai, Guangdong, China

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →