[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590399":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":38,"locations":47,"responsibleParty":82,"collaborators":10,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":10,"eligibilityCriteria":89,"healthyVolunteers":86,"sex":90,"minAge":10,"maxAge":10,"enrollmentInfo":91,"targetDuration":10,"studyType":94,"phases":10,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":50,"whyStopped":10,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"In-Hospital HBV Linkage-to-Care Cohort",null,"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.",[13],"Other: Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department.",{"label":15,"type":10,"description":16,"interventionNames":17},"Antiviral Therapy PRO Cohort","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.",[18],"Other: Assessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B.",[20,24],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"Facilitate the referral of in-hospital chronic hepatitis B patients and provide treatment and follow-up in the infectious disease department.","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.",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"Assessment of patient-reported outcomes (PROs) in patients with chronic hepatitis B.","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.",[15],[29,32,35],{"name":30,"affiliation":5,"role":31},"Liang Peng","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"Zhongsi Hong","Fifth Affiliated Hospital, Sun Yat-Sen University",{"name":36,"affiliation":37,"role":31},"Fangfang Wei","Sixth Affiliated Hospital, Sun Yat-sen University",[39,43],{"name":30,"role":40,"phone":41,"phoneExt":10,"email":42},"CONTACT","+8613533978874","pliang@mail.sysu.edu.cn",{"name":44,"role":40,"phone":45,"phoneExt":10,"email":46},"Qiumin Luo","+8618629634720","luoqm7@mail.sysu.edu.cn",[48,66,73],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"The Third Affiliated Hospital of Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510630","China","CN",{"type":57,"coordinates":58},"Point",[59,60],113.25,23.11667,{"lat":60,"lon":59},[63],{"name":64,"role":40,"phone":65,"phoneExt":10,"email":42},"Liang Peng, PhD","+86 13533978874",{"facility":67,"status":68,"city":51,"state":52,"zip":69,"country":54,"countryCode":55,"cosmosGeoPoint":70,"geoPoint":72,"contacts":10},"The Sixth Affiliated Hospital of Sun Yat-sen University","COMPLETED","510655",{"type":57,"coordinates":71},[59,60],{"lat":60,"lon":59},{"facility":74,"status":68,"city":75,"state":52,"zip":76,"country":54,"countryCode":55,"cosmosGeoPoint":77,"geoPoint":81,"contacts":10},"The Fifth Affiliated Hospital of Sun Yat-sen University","Zhuhai","519000",{"type":57,"coordinates":78},[79,80],113.56778,22.27694,{"lat":80,"lon":79},{"type":31,"investigatorFullName":30,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Professor","100590399","hospital-based-management-of-patients-with-chronic-hepatitis-b-virus-infection-100590399",false,"NCT06966908","Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection","Inclusion Criteria:\n\n* HBsAg-positive patients attending non-infectious disease\u002Fhepatology departments at three study centers.\n\nAdditional inclusion criteria for the PRO sub-study:\n\n* Age ≥ 18 years;\n* Treatment-naïve HBV-infected patients;\n* Meet the treatment criteria according to the \"Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B\" (2022 version);\n* Be able to understand the study content, willing to participate, and sign the informed consent;\n* Have the ability to complete questionnaires independently or with assistance.\n\nExclusion Criteria:\n\n* HBsAg-positive patients already under regular follow-up in infectious disease\u002Fhepatology clinics.\n* Chronic HBV patients on regular antiviral treatment.\n\nAdditional exclusion criteria for the PRO sub-study:\n\n* 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.);\n* Pregnant or lactating women;\n* Use of pegylated interferon during the study;\n* Failure to complete all follow-up visits;\n* Other conditions that the investigator deems inappropriate for participation.","ALL",{"count":92,"type":93},16300,"ESTIMATED","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\u002Fnon-infectious disease departments to 50%. The secondary objective is to improve the treatment rate of hepatitis B infected patients in non-hepatology\u002Fnon-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.",[97],"Chronic Hepatitis B",[97,99,100,101],"linkage to care","management","patient reported outcome","2026-04-02",{"date":104,"type":105},"2026-04-08","ACTUAL",{"date":107,"type":105},"2025-01-03",{"date":109,"type":93},"2027-12-31",{"name":5,"class":6},3]