[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100276849":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":21,"studyPopulation":22,"armGroups":23,"interventions":32,"overallOfficials":38,"centralContacts":42,"locations":51,"responsibleParty":68,"collaborators":17,"id":71,"slug":17,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":17,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":17,"studyType":83,"phases":17,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":54,"whyStopped":17,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"relapse","non-relapse:serum HBV DNA \\\u003C 2000 IU\u002Fml; virologic relapse: serum HBV DNA \\> 2000 IU\u002Fml; clinical relapse:serum HBV DNA \\> 2000 IU\u002Fml and ALT \\> 2×ULN","up to 48 weeks",[14],{"measure":15,"description":16,"timeFrame":12},"occurence of cirrhosis and hepatocellular carcinoma","sign of cirrhosis and hepatocellular carcinoma through ultrasonography",null,{"allocation":17,"interventionModel":17,"interventionModelDescription":17,"primaryPurpose":17,"observationalModel":19,"timePerspective":20,"maskingInfo":17},"COHORT","PROSPECTIVE","Patients with chronic hepatitis b were enrolled in the study. Age, sex, weight, height, symptoms (e.g., fatigue, poor appetite, jaundice), relapse, retreatment, occurrence of liver cirrhosis and hepatocellular carcinoma (HCC), mortality and survival rate were recorded in the study. We also observed the laboratory tests including the levels of white blood cells (WBC), red blood cells (RBC), hemoglobin (HGB), platelet (PLT), alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin (TBIL), blood urea nitrogen (BUN), creatine, hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), hepatitis B virus (HBV) DNA, CD4 positive T lymphocyte (CD4+T), CD8 positive T lymphocyte (CD8+T), Type 1 helper T lymphocyte (Th1), Type 2 helper T lymphocyte (Th2),fibroscan and B ultrasound. If clinical relapse occurred, patients were retreated with nucleos(t)ide analogs.","patients of chronic hepatitis b",[24,29],{"label":25,"type":17,"description":26,"interventionNames":27},"retreatment","1. Patients with HBV DNA \\> 2000 IU\u002Fml and ALT ≥ 5×ULN;\n2. Patients with HBV DNA \\> 2000 IU\u002Fml and 2×ULN \\\u003C ALT ≤ 5×ULN, but have clinical symptoms.\n\nIntervention: Patients of this group will receive Entecavir 0.5mg\u002Fd or Tenofovir 300mg\u002Fd again.",[28],"Drug: Entecavir or Tenofovir",{"label":30,"type":17,"description":31,"interventionNames":17},"non-retreatment","1. Patients with HBV DNA ≤ 2000 IU\u002Fml;\n2. Patients with HBV DNA \\> 2000 IU\u002Fml and ALT ≤ 2×ULN;\n3. Patients with HBV DNA \\> 2000 IU\u002Fml and 2×ULN \\\u003C ALT ≤ 5×ULN, but have no clinical symptoms.",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":17},"DRUG","Entecavir or Tenofovir","Patients in retreatment group receive nucleos(t)ide analogs therapy (Entecavir 0.5mg\u002Fd or Tenofovir 300mg\u002Fd) again",[25],[39],{"name":40,"affiliation":5,"role":41},"Liang Peng, Doctor","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":17,"email":47},"Wenxiong Xu, Master","CONTACT","+8613760783281","xwx1983@163.com",{"name":40,"role":45,"phone":49,"phoneExt":17,"email":50},"+8613533978874","pzp33@hotmail.com",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"The Third Affiliated Hospital of Sun Yat-sen University","RECRUITING","Guangzhou","Guangdong","510630","China","CN",{"type":61,"coordinates":62},"Point",[63,64],113.25,23.11667,{"lat":64,"lon":63},[67],{"name":40,"role":45,"phone":49,"phoneExt":17,"email":50},{"type":41,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"Liang Peng","Associated Professor","100276849",false,"NCT02883647","Therapeutic Effects and Long-term Follow-up After Ending Nucleos(t)Ide Analogs Therapy in Chronic Hepatitis b","Clinical Investigation About Therapeutic Effects and Long-term Follow-up After Ending Anti-hepatitis B Virus Therapy With Nucleos(t)Ide Analogs in Patients With Chronic Hepatitis b","Inclusion Criteria:\n\n1. Patients received anti-HBV therapy with nucleos(t)ide analogs.\n2. Last anti-HBV therapy should continue for at least 2 years.\n3. For HBeAg positive patients, HBV DNA should keep negative for at least 1 year after HBeAg seroconversion before the therapy ending; for HBeAg negative patients, HBV DNA should keep negative for at least 2 years before the therapy ending.\n\nExclusion Criteria:\n\n1. Liver cirrhosis, HCC;\n2. Patients with other factors causing active liver diseases;\n3. Pregnancy or lactation;\n4. Patients with HIV infection or congenital immune deficiency diseases;\n5. Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications.","ALL","18 Years","65 Years",{"count":81,"type":82},100,"ESTIMATED","OBSERVATIONAL","The study is to observe the therapeutic effects and long-term follow-up after ending anti-HBV therapy with nucleos(t)ide analogs in patients with chronic hepatitis b.",[86],"Chronic Hepatitis b",[88],"chronic hepatitis b, nucleos(t)ide analog","2024-11-26",{"date":91,"type":92},"2024-11-29","ACTUAL",{"date":94,"type":17},"2014-01-01",{"date":96,"type":82},"2024-12-31",{"name":5,"class":6},1]