[{"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":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":56,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":56,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":41,"whyStopped":56,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"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","phase-4-study-of-tenofovir-alafenamide-in-hbv-infected-pregnant-women-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":76,"type":77},50,"ESTIMATED","INTERVENTIONAL",[80],"PHASE4","The purpose of this study is to evaluate the pharmacokinetics, efficacy and safety of TAF in HBV-infected pregnant women.",[83,84],"Chronic Hepatitis b","Tenofovir Alafenamide Fumarate",[86,87,21,88,89],"pharmacokinetics","CHB","pregnancy","mother-to-child transmission","2025-08-31",{"date":92,"type":93},"2025-09-08","ACTUAL",{"date":95,"type":93},"2021-05-06",{"date":97,"type":77},"2025-12-30",{"name":5,"class":6},1]