An observational study in Chronic Hepatitis B, sponsored by Third Affiliated Hospital, Sun Yat-Sen University. Recruiting at 3 sites in China. Per ClinicalTrials.gov, last updated 2026-04-08.
Sponsored by Third Affiliated Hospital, Sun Yat-Sen University · Observational
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.
The "Hot wave Project" aims to establish a multicenter management cohort for HBsAg-positive patients within hospitals. Led by infectious disease specialists, the program conducts regular hepatitis B training sessions for hospital staff to enhance their understanding of HBV prevention and control. This initiative seeks to increase HBsAg screening rates overall and encourage patients from non-infectious disease departments to seek referrals to specialized care.
For all paper reports containing HBsAg test results, a remark is added stating: "HBsAg (+) - Recommended to visit the Hepatitis B Health Clinic in the Infectious Disease Department." Positive HBsAg results are automatically extracted by the information system and sent to a dedicated computer in the Hepatitis B Health Clinic, enabling centralized digital patient management.
Additionally, the Infectious Disease Department appoints a "Hepatitis B Specialist Assistant" responsible for reviewing HBsAg screening results, notifying HBsAg-positive patients or their attending physicians, and establishing follow-up records for all patients. A "Hepatitis B Health Clinic" is also set up within the department, managed by a specialized medical team that handles the diagnosis, treatment, and education for referred chronic hepatitis B patients.
Building upon this comprehensive management cohort, the project was expanded in 2025 to include a prospective Patient-Reported Outcomes (PRO) sub-study. This sub-study is designed to evaluate the longitudinal impact of antiviral therapy on the Health-Related Quality of Life among treatment-naïve patients with chronic hepatitis B. Utilizing the validated, localized Chronic Hepatitis B Quality of Life Scale (CHBQOL), the study assesses patients across four key dimensions-physical symptoms, emotional symptoms, beliefs, and social stigma-at baseline, 24 weeks, and 48 weeks post-treatment. By integrating PROs into clinical practice, the Hot wave Project goes beyond traditional biological endpoints to understand the challenges and benefits of HBV treatment from the patient's perspective, ultimately fostering a more patient-centered approach to chronic disease management.
895 studies on the registry are indexed under Hepatitis B, Chronic; 151 are open to participants now.
This study's planned enrollment of 16,300 is above the median of 400 across 206 observational studies indexed under Hepatitis B, Chronic.
Browse Hepatitis B, Chronic studies →Third Affiliated Hospital, Sun Yat-Sen University is the lead sponsor of 133 studies on the registry; 35 are open to participants now.
Counted across the registry records on this site, refreshed daily.
HBsAg-positive patients attending non-infectious disease/hepatology departments.
PRO sub-study: Adult patients who have not previously received treatment and have been diagnosed with chronic hepatitis B
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Additional inclusion criteria for the PRO sub-study:
Exclusion Criteria:
Additional exclusion criteria for the PRO sub-study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This cohort consists of HBsAg-positive patients identified in non-hepatology and non-infectious disease departments across three participating medical centers from. An estimated 16,000 patients will be included in this prospective management cohort.Participants in this cohort are managed under the multidisciplinary "Hot wave Project 2.0" workflow. Positive HBsAg results are automatically captured by the hospital information system and flagged with cautionary remarks. Full-time project nurses proactively contact these patients via telephone, providing them with patient education materials, a quick medical consultation card, and encouraging them to visit the dedicated "Hepatitis B Health Clinic" within 2 weeks.
Other: Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department.
This cohort consists of adult (≥ 18 years), treatment-naïve patients with chronic hepatitis B enrolled from the "Hot wave Project 2.0" management cohort. Eligible patients must meet the indications for antiviral treatment according to the 2022 Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B.Participants in this observational cohort will initiate standard-of-care antiviral therapy as prescribed by their physicians. Throughout the study, their Health-Related Quality of Life will be longitudinally assessed using the localized Chronic Hepatitis B Quality of Life Scale (CHBQOL). PRO assessments, alongside routine clinical parameters will be systematically collected at baseline (Week 0), and at 24 weeks and 48 weeks post-treatment. The target enrollment for this cohort is 300 participants.
Other: Assessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B.
After visiting the hospital, high-risk HBV patients are prescribed HBsAg testing by their primary physician. If HBsAg positivity is detected in patients from non-infectious disease departments, their lab reports will include a reminder to visit the Hepatitis B Health Clinic. Some primary physicians may also request an infectious disease consultation or recommend patient referral. Additionally, within two weeks, the Hepatitis B Specialist Assistant will contact the patients by phone to provide referral recommendations. Once referred to the Hepatitis B Health Clinic, physicians will conduct health education, complete liver function and virological assessments, and develop individualized treatment and follow-up plans.
Patients with chronic hepatitis B who meet treatment criteria and have not previously received treatment will undergo a routine clinical evaluation in a private setting under the guidance of trained staff and complete the Chronic Hepatitis B Quality of Life (CHBQOL) questionnaire prior to initiating standard antiviral therapy (baseline, Week 0). Subsequently, patients will return for scheduled follow-up visits at Weeks 24 and 48 after treatment initiation. During follow-up visits, physicians will assess liver function and virological suppression. Additionally, the CHBQOL questionnaire will be administered again to evaluate changes in patients' health-related quality of life over time, as well as to monitor medication adherence and adverse events.
Referral Rate
Referral rate of HBsAg-positive patients in non-infectious disease departments = Number of HBsAg-positive patients referred to infectious disease departments / Total number of HBsAg-positive patients in non-infectious disease departments.
Time frame: 2 weeks
Changes in Health-Related Quality of Life assessed by the CHBQOL Scale
Patient-Reported Outcomes (PROs) and HRQoL are evaluated using the validated, localized Chronic Hepatitis B Quality of Life Scale (CHBQOL). The CHBQOL comprises 23 items categorized into four dimensions: physical symptoms, emotional symptoms, beliefs, and social stigma. This measure will calculate the longitudinal changes in both the total CHBQOL score and its dimension-specific sub-scores before and after initiating standard antiviral therapy. The objective is to quantify the impact of antiviral treatment on the quality of life in treatment-naïve CHB patients.
Time frame: Baseline (Week 0), week 24, and week 48
Antiviral Treatment Rate
Antiviral treatment rate of HBsAg-positive patients in non-infectious disease departments = Number of patients from non-infectious disease departments starting antiviral treatment / Total number of HBsAg-positive patients in non-infectious disease departments.
Time frame: 2 weeks
Incremental Cost-Effectiveness Ratio
This measure evaluates the long-term cost-effectiveness and cost-utility of the "Hot wave" in-hospital management strategy. Real-world data collected from this study-specifically the observed HBV linkage-to-care and treatment initiation rates-will be integrated into a validated decision-analytic Markov model. The model will be parameterized with localized epidemiological and demographic data from Guangzhou . By simulating different policy scenarios over a lifetime horizon, the model will predict cumulative costs and health outcomes, including Quality-Adjusted Life Years (QALYs) and the number of averted HBV-related complications . The final outcome will be expressed as the Incremental Cost-Effectiveness Ratio, representing the cost per additional QALY gained compared to the status quo.
Time frame: 3 years
Correlation Between HRQoL Changes and Clinical Responses
To evaluate the relationship between the longitudinal changes in CHBQOL scores (Patient-Reported Outcomes) and key clinical efficacy indicators. Specifically, this measure will analyze how achieving virological suppression (undetectable HBV DNA) and biochemical response (ALT normalization) correlates with improvements or declines in patients' Health-Related Quality of Life during the antiviral treatment period.
Time frame: Baseline (Week 0), Week 24, and Week 48
Predictive Factors Affecting HRQoL Changes
To analyze the sociodemographic and clinical factors that significantly influence the trajectory of PRO changes in CHB patients undergoing antiviral therapy. Evaluated factors will include, but are not limited to, patient age, gender, baseline liver fibrosis stage (assessed via FibroScan scores or imaging), and the presence of comorbidities. This analysis aims to identify specific patient subgroups that may require additional clinical attention or distinct management strategies to improve their quality of life.
Time frame: Baseline (Week 0), Week 24, and Week 48
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Plan to share: Undecided
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Started Jan 2025 (actual). Primary completion is estimated for Jun 2027, 29 months after the start.
Of 71 observational studies under Hepatitis B, Chronic, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 99. This study's planned 29 months is below that.
How these figures are worked out, and which studies are left out of them.
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