[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Qing-Lei Zeng\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":4},"100619514","phase-4-entecavir-with-or-without-pegylated-interferon--2b-in-children-aged-3-6-years-with-immune-active-chronic-hepatitis-b-100619514",false,"NCT07345611","Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Active Chronic Hepatitis B","Efficacy and Safety of Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3 to 6 Years With Chronic Hepatitis B in the Immune-Clearance Phase (B-Young-Cure-2): A Multicenter, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age between 3 and 6 (more than 3 but less than 7) years;\n2. Chronic HBV infection;\n3. Positive HBeAg;\n4. HBV DNA \\>1.0×10⁴ IU\u002FmL;\n5. Normal upper abdominal ultrasound without cirrhosis or hepatocellular carcinoma;\n6. ALT \\>40 U\u002FL.\n\nExclusion Criteria:\n\n1. Previous antiviral treatment for chronic HBV infection;\n2. Coinfection with hepatitis C, D, E, human immunodeficiency virus (HIV), Epstein-Barr virus, or cytomegalovirus;\n3. Previous or current evidence of hepatocellular carcinoma or cirrhosis;\n4. Coexistence of any other liver diseases such as autoimmune hepatitis, drug-induced liver injury or Wilson's disease;\n5. Coexistence of systemic\u002Fother organ disorders (for example with evidence of thyroid disorders);\n6. Hemoglobin level \\\u003C100 g\u002FL;\n7. Absolute neutrophil count \\\u003C1.0×10⁹\u002FL.;\n8. Platelet count \\\u003C125×10⁹\u002FL;\n9. Total bilirubin \\>1 ULN, i.e., 17.1 μmol\u002FL;\n10. Albumin level \\\u003C35 g\u002FL;\n11. Concurrent treatment with other drugs, including but not limited to nephrotoxic drugs, immune modulators, cytotoxic drugs, Chinese traditional medicine or supplements, nonsteroidal anti-inflammatory drugs, or steroids.","ALL","3 Years","6 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This study aims to evaluate the efficacy and safety of entecavir monotherapy versus sequential entecavir plus pegylated interferon α-2b in achieving functional cure in immune-active, HBeAg-positive children aged 3-6 years with chronic hepatitis B.",[27,28,29],"Hepatitis B Virus Infection","Children","Chronic Hepatitis B",[28,31,32,33,34,35,36,37,38],"Efficacy","Immune clearance","Safety","Chronic","Entecavir","Pegylated interferon α-2b","Functional cure","Hepatitis B virus","NOT_YET_RECRUITING","2026-01-07",{"date":42,"type":43},"2026-01-16","ACTUAL",{"date":45,"type":21},"2026-01-11",{"date":47,"type":21},"2030-12-31",{"name":49,"class":50},"Qing-Lei Zeng","OTHER",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":68,"locationsCount":4},"100619515","phase-4-entecavir-with-or-without-pegylated-interferon--2b-in-children-aged-3-6-years-with-immune-tolerant-chronic-hepatitis-b-100619515","NCT07345624","Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3-6 Years With Immune-Tolerant Chronic Hepatitis B","Efficacy and Safety of Entecavir With or Without Pegylated Interferon α-2b in Children Aged 3 to 6 Years With Immune-Tolerant Chronic Hepatitis B Virus Infection (B-Young-Cure-1): A Multicenter, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged 3-6 (more than 3 but less than 7) years;\n2. With chronic HBV infection;\n3. HBeAg-positive;\n4. HBV DNA \\>1.0×10⁷ IU\u002FmL;\n5. Normal upper abdominal ultrasound;\n6. ALT \\\u003C40 U\u002FL, HBsAg positivity, HBeAg positivity, and HBV DNA\\>1.0×10⁷IU\u002FmL for at least two times, with an interval of 6 months or more.\n\nExclusion Criteria:\n\n1. Previous antiviral treatment for chronic HBV infection;\n2. Coinfection with hepatitis C, D, E, human immunodeficiency virus (HIV), Epstein-Barr virus, or cytomegalovirus;\n3. Previous or current evidence of hepatocellular carcinoma or cirrhosis;\n4. Coexistence of any other liver diseases such as autoimmune hepatitis, drug-induced liver injury or Wilson's disease;\n5. Coexistence of systemic\u002Fother organ disorders (for example with evidence of thyroid disorders);\n6. Hemoglobin level \\\u003C100 g\u002FL.\n7. Absolute neutrophil count \\\u003C1.0×10⁹\u002FL;\n8. Platelet count \\\u003C125×10⁹\u002FL;\n9. Total bilirubin \\>1 ULN, i.e., 17.1 μmol\u002FL;\n10. Albumin level \\\u003C35 g\u002FL;\n11. Concurrent treatment with other drugs, including but not limited to nephrotoxic drugs, immune modulators, cytotoxic drugs, Chinese traditional medicine or supplements, nonsteroidal anti-inflammatory drugs, or steroids.",{"count":59,"type":21},80,[24],"This study aims to evaluate the efficacy and safety of entecavir monotherapy versus sequential entecavir plus pegylated interferon α-2b in achieving functional cure in immune-tolerant, HBeAg-positive children aged 3-6 years with chronic hepatitis B virus infection.",[27,28,29],[28,31,33,34,36,38,35,37,64],"Immune-tolerant",{"date":42,"type":43},{"date":45,"type":21},{"date":47,"type":21},{"name":49,"class":50},""]