[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504852":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":28,"locations":38,"responsibleParty":63,"collaborators":56,"id":65,"slug":56,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":56,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":56,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":84,"overallStatus":41,"whyStopped":56,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"First People's Hospital of Hangzhou","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"TAF antiviral therapy group","EXPERIMENTAL","Eligible hepatitis B pregnant women are given TAF antiviral therapy (25mg, oral, 1\u002Fday) from week 28-32 of gestation until delivery",[13],"Drug: Tenofovir Alafenamide Tablets",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Tenofovir Alafenamide Tablets","Take 25mg TAF daily from week 28-32 of gestation until delivery",[9],[21],"TAF",[23,26],{"name":24,"affiliation":5,"role":25},"Zhiyuan Ma, PhD","PRINCIPAL_INVESTIGATOR",{"name":27,"affiliation":5,"role":25},"Siying Li, MD",[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Jie Jin, MD","CONTACT","13372517879","86","jinjie0429@163.com",{"name":24,"role":31,"phone":36,"phoneExt":33,"email":37},"18858273870","zhiyuan_ma@zju.edu.cn",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hangzhou First People's Hospital","RECRUITING","Hangzhou","Zhejiang","310000","China","CN",{"type":48,"coordinates":49},"Point",[50,51],120.16142,30.29365,{"lat":51,"lon":50},[54,55,57,58,61],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},{"name":24,"role":25,"phone":56,"phoneExt":56,"email":56},null,{"name":27,"role":25,"phone":56,"phoneExt":56,"email":56},{"name":59,"role":60,"phone":56,"phoneExt":56,"email":56},"Yi Jiang, MD","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":56,"phoneExt":56,"email":56},"Jinfeng Shi, MD",{"type":64,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR","100504852",false,"NCT05853718","Study of Tenofovir Alafenamide in HBV-Infected Pregnant Women","Study to Evaluate the Pharmacokinetic, Safety, and Efficacy of TAF in HBV-Infected Pregnant Women","Inclusion Criteria:\n\n* Age of 20-40 years; Positive for hepatitis B surface antigen (HBsAg) and hepatitis B virus e antigen (HBeAg); HBV DNA level \\>200 000 IU\u002FmL during the 24th-32nd week of pregnancy; Willing to take TAF for mother-to-child blockade; Both husband and wife are willingly sign an informed consent.\n\nExclusion Criteria:\n\n* Co-infected with hepatitis C or HIV, or other chronic diseases; History of spontaneous abortion or congenital malformation; Decompensated cirrhosis and liver cancer; History of kidney injury, CCr \\\u003C50ml\u002Fmin and urine protein test positive (\\>300mg\u002FL); Fetal malformations detected by B-ultrasound during pregnancy; ALT \\> 2×upper limit of normal (ULN); TBIL ≥ 1×ULN; Albumin (ALB) \\\u003C 25 g\u002FL.","FEMALE","20 Years","40 Years",{"count":75,"type":76},50,"ESTIMATED","INTERVENTIONAL",[79],"PHASE4","The purpose of this study is to evaluate the pharmacokinetics, efficacy and safety of TAF in HBV-infected pregnant women.",[82,83],"Chronic Hepatitis b","Tenofovir Alafenamide Fumarate",[85,86,21,87,88],"pharmacokinetics","CHB","pregnancy","mother-to-child transmission","2025-08-31",{"date":91,"type":92},"2025-09-08","ACTUAL",{"date":94,"type":92},"2021-05-06",{"date":96,"type":76},"2025-12-30",{"name":5,"class":6},1]