[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100431297":3},{"organization":4,"outcomesModule":7,"designInfo":52,"detailedDescription":55,"studyPopulation":56,"armGroups":57,"interventions":72,"overallOfficials":81,"centralContacts":93,"locations":103,"responsibleParty":119,"collaborators":122,"id":158,"slug":53,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":159,"sex":165,"minAge":166,"maxAge":53,"enrollmentInfo":167,"targetDuration":170,"studyType":171,"phases":53,"briefSummary":172,"conditions":173,"keywords":53,"overallStatus":105,"whyStopped":53,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":184},{"fullName":5,"class":6},"Huashan Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"rate of hepatocellular carcinoma at 5 year from baseline","Rate of hepatocellular carcinoma will be evaluated as an end-stage liver disease event at 5 years from baseline","5 year from baseline",[14,18,22,26,29,32,35,38,41,44],{"measure":15,"description":16,"timeFrame":17},"rate of HBsAg loss","rate of HBsAg loss will be measured as a serological response event at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively.","24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline",{"measure":19,"description":20,"timeFrame":21},"rate of decompensated cirrhosis","Rate of decompensated cirrhosis will be evaluated as an end-stage liver disease event at 1year, 2 year, 3 year, 4 year, and 5 year from baseline","1year, 2 year, 3 year, 4 year and 5 year from baseline",{"measure":23,"description":24,"timeFrame":25},"rate of cirrhosis","rate of cirrhosis at 1 year, 2 year, 3 year, 4year, and 5 year from baseline","1 year, 2 year, 3 year, 4year, and 5 year from baseline",{"measure":27,"description":28,"timeFrame":17},"rate of fibrosis progression","rate of fibrosis progression will be measured as a histological response event at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively.",{"measure":30,"description":31,"timeFrame":17},"rate of fibrosis regression","rate of fibrosis regression will be measured as a histological response event at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively.",{"measure":33,"description":34,"timeFrame":12},"rate of liver transplantation","Rate of liver transplantation will be evaluated as an end-stage liver disease event at 5 year from baseline",{"measure":36,"description":37,"timeFrame":17},"HBsAg level","HBsAg level will be measured at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively, and kinetics will be described based on the results.",{"measure":39,"description":40,"timeFrame":17},"rate of HBeAg loss","rate of HBeAg loss will be measured as a serological response event at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively.",{"measure":42,"description":43,"timeFrame":17},"rate of HBeAg conversion","rate of HBeAg conversion will be measured as a serological response event at 24 weeks, 48 weeks, 72 weeks, 96 weeks, 120 weeks, 144 weeks, 168 weeks, 192 weeks, 216 weeks, 240 weeks from baseline, respectively.",{"measure":45,"description":46,"timeFrame":21},"rate of HBV DNA undetectable","Rate of HBV DNA undetectable will be evaluated as an end-stage liver disease event at 1year, 2 year, 3 year, 4 year, and 5 year from baseline",[48],{"measure":49,"description":50,"timeFrame":51},"demographic characteristics","demographic characteristics at baseline","baseline",{"allocation":53,"interventionModel":53,"interventionModelDescription":53,"primaryPurpose":53,"observationalModel":54,"timePerspective":6,"maskingInfo":53},null,"COHORT","The OASIS study is a multicenter, observational, real-world cohort study designed to evaluate long-term outcomes of antiviral therapies for chronic hepatitis B (CHB). It compares nucleos(t)ide analogue (NA) monotherapy, pegylated interferon based regimen without randomization or blinding. Treatment decisions follow routine clinical guidelines, physician expertise, and patient-specific factors. The study includes three cohorts: Prospective (PS, 5-year follow-up post-consent), Retrospective-Prospective (RPS, retrospective from baseline ≥September 2020 to consent, then 5-year prospective), and Retrospective (RS, data from September 2020 to protocol implementation). The target of 33,000 patients was determined based on patient flow across sub-centers, ensuring sufficient power to detect differences in 5-year HCC incidence (primary endpoint) and secondary outcomes (e.g., HBsAg seroclearance rates).","patients with chronic hepatitis B under anti-viral treatment of peginterferon alpha based regimen or nucleos(t)ide alone.",[58,64,68],{"label":59,"type":53,"description":60,"interventionNames":61},"Prospective","CHB patients enrolled pre-Protocol v3.0 (Dec 2023), planned or on antiviral therapy, followed prospectively for 5 years post-consent. Treatments: routine NA monotherapy, or PegIFN based regimens, per clinical guidelines. Data: baseline and 5 -year follow-up via routine visits.",[62,63],"Drug: peginterferon alpha based regimen","Drug: nucleos(t)ide",{"label":65,"type":53,"description":66,"interventionNames":67},"Retrospective-Prospective","CHB patients with baseline (≥Sep 2020) pre-v3.0, consenting post-v3.0. Retrospective data from baseline to consent; prospective for 5 years from baseline. Treatments: NAs monotherapy, or PegIFN based regimens. Data: retrospective before consent; prospective from visit matching baseline-consent interval. Missing routine data noted.",[62,63],{"label":69,"type":53,"description":70,"interventionNames":71},"Retrospective","CHB patients with records from Sep 2020 to v3.0 (Dec 2023), collected retrospectively. Treatments: NAs monotherapy, or PegIFN based regimens, per historical practice. Data: extracted from the electronic healthcare record; missing routine data recorded.",[62,63],[73,78],{"type":74,"name":75,"description":76,"armGroupLabels":77,"otherNames":53},"DRUG","peginterferon alpha based regimen","peginterferon alpha based regimen or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study",[59,69,65],{"type":74,"name":79,"description":76,"armGroupLabels":80,"otherNames":53},"nucleos(t)ide",[59,69,65],[82,85,87,90],{"name":83,"affiliation":5,"role":84},"Wenhong Zhang, MD","PRINCIPAL_INVESTIGATOR",{"name":86,"affiliation":5,"role":84},"Jiming Zhang, MD",{"name":88,"affiliation":5,"role":89},"Feng Sun, MD","STUDY_CHAIR",{"name":91,"affiliation":5,"role":92},"Qiran Zhang, MD","STUDY_DIRECTOR",[94,99],{"name":95,"role":96,"phone":97,"phoneExt":53,"email":98},"Wenhong Zhang, Professor","CONTACT","13801844344","zhangwenhong@fudan.edu.cn",{"name":100,"role":96,"phone":101,"phoneExt":53,"email":102},"Feng Sun, doctor","15921403893","aaronsf1125@126.com",[104],{"facility":5,"status":105,"city":106,"state":53,"zip":107,"country":108,"countryCode":109,"cosmosGeoPoint":110,"geoPoint":115,"contacts":116},"RECRUITING","Shanghai","200040","China","CN",{"type":111,"coordinates":112},"Point",[113,114],121.45806,31.22222,{"lat":114,"lon":113},[117,118],{"name":95,"role":96,"phone":97,"phoneExt":53,"email":98},{"name":100,"role":96,"phone":101,"phoneExt":53,"email":102},{"type":84,"investigatorFullName":120,"investigatorTitle":121,"investigatorAffiliation":5,"oldNameTitle":53,"oldOrganization":53},"Wen-hong Zhang","Professor",[123,126,128,130,132,134,136,138,140,142,144,146,148,150,152,154,156],{"name":124,"class":125},"Chinese Foundation for Hepatitis Prevention and Control","UNKNOWN",{"name":127,"class":6},"The Third People's Hospital of Taiyuan",{"name":129,"class":6},"First Affiliated Hospital of Chongqing Medical University",{"name":131,"class":6},"Beijing YouAn Hospital",{"name":133,"class":6},"Henan Provincial People's Hospital",{"name":135,"class":125},"Yunnan Provincial No.1 Hospital",{"name":137,"class":6},"Third Affiliated Hospital, Sun Yat-Sen University",{"name":139,"class":6},"The First Affiliated Hospital of Anhui Medical University",{"name":141,"class":6},"The First Affiliated Hospital of Xiamen University",{"name":143,"class":6},"Beijing Ditan Hospital",{"name":145,"class":125},"Tianjing No.2 People's Hospital",{"name":147,"class":125},"Qingdao No.6 People's Hospital",{"name":149,"class":6},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine",{"name":151,"class":6},"Ningbo Beilun District Traditional Chinese Medicine Hospital",{"name":153,"class":125},"Wuxi No.5 People's Hospital",{"name":155,"class":125},"Taicang No.1 People's hospital",{"name":157,"class":6},"First Affiliated Hospital Xi'an Jiaotong University","100431297",false,"NCT04896255","Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B","Long-term Outcomes of Anti-viral Therapies in Patients With Chronic Viral Hepatitis B: A Multicenter, Real-world Study","OASIS","Inclusion Criteria:\n\n* Male and female patients with age ≥18; subjects who are over 70 years of age must be in generally stable health conditions.\n* There should be evidences that HBsAg has been positive for more than 6 months or HBV-related histological changes.\n* Planned or currently receiving potent low-resistance NAs \\[entecavir (ETV), tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or tenofovir amibufenamide (TMF)\\], or planned to receive PegIFNα-2b, either treated or treatment-naïve.\n* Agree to participate in the study and sign the patient informed consent form.\n\nExclusion Criteria:\n\n* Hepatocellular carcinoma (diagnosed or planned for treatment) or liver failure at baseline\n* Concurrently participating in other interventional clinical trials.\n* Any other conditions deemed unsuitable by investigators or preventing compliance with study requirements.","ALL","18 Years",{"count":168,"type":169},33000,"ESTIMATED","5 Years","OBSERVATIONAL","The goal of this observational, multicenter , real-world study is to evaluate the long-term outcomes of different antiviral therapies in adults with chronic hepatitis B (CHB). The main questions it aims to answer are: What is the 5-year incidence of hepatocellular carcinoma (HCC) under various treatment regimens? How do rates of HBsAg seroclearance, decompensated cirrhosis, liver fibrosis progression, and other virological and clinical outcomes compare across regimens? Researchers will compare real-world treatment arms-including nucleos(t)ide analogue (NA) monotherapy (e.g., entecavir, tenofovir), PegIFN based regimen (e.g., PegIFN monotherapy, PegIFN plus NA combinations)-to identify optimal strategies for reducing HCC risk and improving functional cure rates.\n\nParticipants will undergo routine clinical care with no study-imposed interventions; data on demographics, medical history, symptoms, laboratory tests (e.g., HBsAg, HBV DNA, liver function), imaging (e.g., ultrasound, elastography), and clinical events will be collected prospectively (for up to 5 years in some cohorts) or retrospectively from medical records at baseline and scheduled follow-up visits (e.g., every 3-12 months initially, then annually).",[174],"Chronic Hepatitis b","2025-09-30",{"date":177,"type":178},"2025-10-06","ACTUAL",{"date":180,"type":178},"2020-09-09",{"date":182,"type":169},"2031-12-31",{"name":5,"class":6},1]