[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554800":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":59,"collaborators":19,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":19,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":19,"maxAge":68,"enrollmentInfo":69,"targetDuration":19,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":19,"overallStatus":78,"whyStopped":19,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"Beijing 302 Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"the antiviral group","EXPERIMENTAL","HBV-infected infants in the treatment group were treated with LAM (4 mg\u002Fkg\u002Fd) before 1 year of age, and then combined with regular interferon (intramuscular or subcutaneous injection, 3-6 million U\u002Fm2 body surface area, every other day, with a starting dose of 3 million U\u002Fm2 body surface area, which was adjusted according to the specific tolerances of the children during the course of the treatment) if they were still HBV DNA and\u002For HBsAg-positive at the end of the 1st year of age. The course of interferon treatment is 52 weeks.",[13,14],"Drug: Lamivudine","Drug: Interferon",{"label":16,"type":17,"description":18,"interventionNames":19},"the control group","NO_INTERVENTION","synchronized follow-up visits without intervention",null,[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":19},"DRUG","Lamivudine","4mg\u002Fkg\u002Fd, oral",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":19},"Interferon","Use only in children who remain positive for HBV-DNA and\u002For HBsAg after 1 year of age. Regular interferon (3 million U\u002Fm2 body surface area, intramuscular or subcutaneous, every other day, adjusted during treatment according to the child's specific tolerance) for 52 weeks.",[9],[31],{"name":32,"affiliation":33,"role":34},"Junliang Fu","The fifth medical center of PLA","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":19,"email":40},"Junliang Fu, PhD, MD","CONTACT","86-10-66933214","fjunliang@163.com",[42],{"facility":43,"status":19,"city":44,"state":19,"zip":19,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"the Fifth Medical Center of PLA","Beijing","China","CN",{"type":48,"coordinates":49},"Point",[50,51],116.39723,39.9075,{"lat":51,"lon":50},[54,55],{"name":37,"role":38,"phone":39,"phoneExt":19,"email":19},{"name":56,"role":38,"phone":57,"phoneExt":19,"email":58},"Fu-Sheng Wang, PhD, MD","86-10-66933328","fswang302@163.com",{"type":60,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100554800","phase-4-antiviral-therapy-in-infants-with-hbv-infection-100554800",false,"NCT06503796","Antiviral Therapy in Infants With HBV Infection","Inclusion Criteria:\n\n* a. Age ≤ 1 year;\n* b. HBsAg and HBV DNA positive;\n* c. ALT ≤ 5 times the upper limit of normal (ULN) and no pathologic jaundice (two consecutive tests with an interval of 2 weeks - 3 months).\n* d. Parents are willing to participate in the study and sign an informed consent form, for children without parents, all legal guardians of need to give informed consent.\n\nExclusion Criteria:\n\n* a. Combined viral infections such as HAV, HCV, HDV, HEV, HIV, EBV, CMV, etc;\n* b. Combination of other liver diseases, such as autoimmune hepatitis, drug-induced liver injury, Wilson's disease;\n* c. WBC \\\u003C9 × 10\\^9\u002FL, or PLT \\\u003C90 × 10\\^9\u002FL;\n* d. Combination of other systemic serious diseases or hereditary diseases, etc;\n* e. Other conditions deemed by the investigator to be unsuitable for participation in this study.","ALL","1 Year",{"count":70,"type":71},60,"ESTIMATED","INTERVENTIONAL",[74],"PHASE4","This study was a multicenter, prospective randomized controlled clinical study. A total of 60 HBV-infected infants with ALT ≤5 times the upper limit of normal (ULN) and without pathological jaundice were enrolled and randomized 1:1 into two groups: the control group and the antiviral treatment group. HBV-infected infants in the treatment group were treated with LAM before the age of 1 year and then combined with regular interferon for 52 weeks if they were still positive for HBV DNA and\u002For HBsAg after reaching the age of 1 year. The control group was followed up synchronously. Follow-up was conducted every 3 months during the study period. The main efficacy evaluation indexes: HBsAg conversion (functional cure) rate, HBeAg conversion rate, HBeAg seroconversion rate, HBV DNA conversion rate, HBsAg seroconversion rate, and ALT reversion rate at the end of 12 months of treatment and at 2 years of age.",[77],"HBV","NOT_YET_RECRUITING","2024-07-21",{"date":81,"type":82},"2024-07-23","ACTUAL",{"date":84,"type":71},"2024-08",{"date":86,"type":71},"2026-11",{"name":5,"class":6},1]