[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100414269":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":32,"responsibleParty":56,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":18,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":78,"whyStopped":18,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"National Cheng-Kung University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"TAF Treatment","EXPERIMENTAL","TAF treatment for 144 weeks and followed for 48 weeks after 144-week TAF treatment",[13],"Drug: Tenofovir Alafenamide",{"label":15,"type":16,"description":17,"interventionNames":18},"Observation arm","NO_INTERVENTION","Observation for 144 weeks",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DRUG","Tenofovir Alafenamide","Tenofovir Alafenamide treatment for 144 weeks",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"Pin-Nan Cheng, MD","CONTACT","886-6-2353535","2679","pncheng@mail.ncku.edu.tw",[33],{"facility":5,"status":34,"city":35,"state":18,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Tainan","704","Taiwan","TW",{"type":40,"coordinates":41},"Point",[42,43],120.21333,22.99083,{"lat":43,"lon":42},[46,49,53],{"name":47,"role":28,"phone":48,"phoneExt":18,"email":31},"Pin-Nan Cheng, PhD","+886-972401223",{"name":50,"role":28,"phone":51,"phoneExt":18,"email":52},"Li-Chen Lin","+886-910819731","lichenlin516@gmail.com",{"name":54,"role":55,"phone":18,"phoneExt":18,"email":18},"Pin-Nan Cheng","PRINCIPAL_INVESTIGATOR",{"type":57,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100414269","phase-4-the-effectiveness-and-safety-of-tenofovir-alafenamide-in-the-treatment-of-chronic-hepatitis-b-patients-with-mildly-elevated-alanine-aminotransferase-and-significant-liver-injury-100414269",false,"NCT04674423","The Effectiveness and Safety of Tenofovir Alafenamide in the Treatment of Chronic Hepatitis B Patients With Mildly Elevated Alanine Aminotransferase and Significant Liver Injury.","The Effectiveness and Safety of Tenofovir Alafenamide in the Treatment of Chronic Hepatitis B Patients With Mildly Elevated Alanine Aminotransferase and Significant Liver Injury","Inclusion Criteria:\n\n* Age more than 20 years\n* Presence of HBsAg positivity for more than 6 months that indicated chronic HBV infection;\n* HBV viral load more than 20000 IU\u002FmL in HBeAg positive or more than 2000 IU\u002FmL in HBeAg Negative CHB patients;\n* Presence of liver injury which was defined as histology activity index (HAI) \\>3 by Knodell necroinflammantion scoring system or liver fibrosis stage 2 or stage 3 by Metavir scoring system; Liver histology available for evaluation 6 months before starting screening is also acceptable. This criteria is limited to subjects enrolling TAF treatment group.\n* ALT level between 1-2 folds of ULN for at least one occasion in recent 1 year before screening;\n* Treatment naïve;\n\nExclusion Criteria:\n\n* Other etiology of chronic hepatitis; Those patients with spontaneous clearance of HCV defined as presence of anti-HCV antibody but undetectable of HCV RNA at least 3 months before enrollment and without history of anti-viral treatment could be included.\n* Severe comorbid disorders;\n* Uncontrolled diabetes mellitus (HBA1c \\> 8.5%);\n* Current evidence or suspicious of malignancy;\n* Diagnosis of liver cirrhosis;\n* eGFR \\\u003C or = 30 ml\u002Fmin\u002F1.73m2.\n* Any one of following hematology or biochemical or clinical abnormalities:\n\nAlbumin \\\u003C3.5g\u002FdL, Total Bilirubin \\>2.5mg\u002FdL, prothrombin time prolongation \\>4 sec or INR \\>1.7, platelet count \\\u003C100 x 103 uL, and history or presence of ascites or hepatic encephalopathy.\n\n* Child-bearing age women without the willing to contraceptive control, or lactating or pregnant women.","ALL","20 Years",{"count":68,"type":69},40,"ESTIMATED","INTERVENTIONAL",[72],"PHASE4","In Taiwan, non-cirrhosis CHB patients with mildly elevated ALT are not candidates for antiviral treatment under Taiwan NIH reimbursement criteria. Disease severity could range from mildly liver injury to cirrhosis in this group of patients. There is a substantial population of patients required antiviral treatment, but not fulfill the criteria of reimbursement treatment.\n\nFor the 2 phase 3 trials of TAF, the treatment criteria of ALT were more than 2x of ULN and did not included liver biopsy as a pre-treatment assessment. In this study, CHB patient with ALT level of 1-2x ULN and significant liver injury evaluated by liver biopsy is the target study population.",[75],"Chronic Hepatitis b",[77],"Chronic hepatitis B, tenofovir Alafenamide, ALT, liver injury","UNKNOWN","2020-12-18",{"date":81,"type":82},"2020-12-22","ACTUAL",{"date":84,"type":82},"2020-05-14",{"date":86,"type":69},"2025-12-31",{"name":5,"class":6},1]