[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619514":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":40,"responsibleParty":46,"collaborators":50,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":40,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":40,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":99,"overallStatus":107,"whyStopped":40,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":40},{"fullName":5,"class":6},"The First Affiliated Hospital of Zhengzhou University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Entecavir","EXPERIMENTAL","Receive entecavir monotherapy throughout the 96-week treatment course.",[13],"Drug: Entecavir",{"label":15,"type":10,"description":16,"interventionNames":17},"Entecavir plus Peg-IFN α-2b","Receive entecavir for the first 48 weeks, followed by combination therapy with pegylated interferon α-2b for the remaining 48 weeks.",[18],"Drug: Entecavir + Pegylated interferon α-2b",[20,26],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Receive entecavir onotherapy throughout the 96-week treatment course, the dosage of entecavir is 0.015 mg\u002Fkg\u002Fday for those weighing between 10 and 30 kg; for those weighing more than 30 kg, the dosage is 0.5 mg\u002Fday, oral.",[9],[25],"Runzhong®",{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Entecavir + Pegylated interferon α-2b","Receive entecavir (with dosing adjusted by body weight: 0.015 mg\u002Fkg\u002Fday for subjects weighing 10-30 kg, and 0.5 mg\u002Fday for those \\>30 kg, oral) for the first 48 weeks, followed by combination therapy with pegylated interferon α-2b (104 μg\u002Fm², weekly, subcutaneous injection) for the remaining 48 weeks.",[15],[25,31],"PEGBING®",[33],{"name":34,"affiliation":5,"role":35},"Qing-Lei Zeng, M.D.","PRINCIPAL_INVESTIGATOR",[37,42],{"name":34,"role":38,"phone":39,"phoneExt":40,"email":41},"CONTACT","86 15838120512",null,"zengqinglei2009@163.com",{"name":43,"role":38,"phone":44,"phoneExt":40,"email":45},"Zu-Jiang Yu, M.D.","86 186 0371 0022","johnyuem@zzu.cn",{"type":47,"investigatorFullName":48,"investigatorTitle":49,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"SPONSOR_INVESTIGATOR","Qing-Lei Zeng","Professor",[51,53,55,57,59,62,64,66,68,70,72,74,76],{"name":52,"class":6},"Henan Provincial People's Hospital",{"name":54,"class":6},"Luoyang Central Hospital",{"name":56,"class":6},"Xuchang Central Hospital",{"name":58,"class":6},"Luohe Central Hospital",{"name":60,"class":61},"Yongcheng People's Hospital","UNKNOWN",{"name":63,"class":6},"Sanmenxia Central Hospital",{"name":65,"class":61},"The Third Affiliated Hospital of Henan Medical University",{"name":67,"class":61},"Weishi County People's Hospital",{"name":69,"class":6},"The Sixth People's Hospital of Zhengzhou",{"name":71,"class":61},"The First Affiliated Hospital of Henan Medical University",{"name":73,"class":61},"Shangcheng County People's Hospital",{"name":75,"class":61},"The First Affiliated Hospital of Henan Polytechnic University",{"name":77,"class":6},"Nanyang Central Hospital","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":89,"type":90},60,"ESTIMATED","INTERVENTIONAL",[93],"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.",[96,97,98],"Hepatitis B Virus Infection","Children","Chronic Hepatitis B",[97,100,101,102,103,9,104,105,106],"Efficacy","Immune clearance","Safety","Chronic","Pegylated interferon α-2b","Functional cure","Hepatitis B virus","NOT_YET_RECRUITING","2026-01-07",{"date":110,"type":111},"2026-01-16","ACTUAL",{"date":113,"type":90},"2026-01-11",{"date":115,"type":90},"2030-12-31",{"name":48,"class":6}]