[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100299635":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":30,"centralContacts":34,"locations":35,"responsibleParty":305,"collaborators":34,"id":307,"slug":308,"hasResults":309,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":34,"eligibilityCriteria":313,"healthyVolunteers":314,"sex":315,"minAge":316,"maxAge":34,"enrollmentInfo":317,"targetDuration":34,"studyType":320,"phases":321,"briefSummary":323,"conditions":324,"keywords":34,"overallStatus":326,"whyStopped":34,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":335},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A (Renal Impairment): Moderate or Severe Renal Impairment","EXPERIMENTAL","Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and taking tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), will switch to tenofovir alafenamide (TAF) and receive TAF 25 milligram (mg) tablet once daily orally for 96 weeks.",[13],"Drug: TAF",{"label":15,"type":10,"description":16,"interventionNames":17},"Part A (Renal Impairment): End Stage Renal Disease","Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, will switch to TAF and receive TAF 25 mg tablet once daily orally for 96 weeks.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Part B: Hepatic Impairment","Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, will switch to TAF and receive TAF 25 mg tablet once daily orally for 96 weeks.",[13],[23],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","TAF","Tablet administered orally once daily",[15,9,19],[29],"Vemlidy®",[31],{"name":32,"affiliation":5,"role":33},"Gilead Study Director","STUDY_DIRECTOR",null,[36,49,58,68,78,89,98,107,113,122,133,140,148,160,169,177,189,199,205,214,220,231,240,249,255,264,273,279,288,299],{"facility":37,"status":34,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":34},"Coalition of Inclusive Medicine","Los Angeles","California","90020","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-118.24368,34.05223,{"lat":47,"lon":46},{"facility":50,"status":34,"city":51,"state":39,"zip":52,"country":41,"countryCode":42,"cosmosGeoPoint":53,"geoPoint":57,"contacts":34},"Silicon Valley Research Institute, Inc","San Jose","95128",{"type":44,"coordinates":54},[55,56],-121.89496,37.33939,{"lat":56,"lon":55},{"facility":59,"status":34,"city":60,"state":61,"zip":62,"country":41,"countryCode":42,"cosmosGeoPoint":63,"geoPoint":67,"contacts":34},"Henry Ford Health System","Detroit","Michigan","48202",{"type":44,"coordinates":64},[65,66],-83.04575,42.33143,{"lat":66,"lon":65},{"facility":69,"status":34,"city":70,"state":71,"zip":72,"country":41,"countryCode":42,"cosmosGeoPoint":73,"geoPoint":77,"contacts":34},"Harborview Medical Center","Seattle","Washington","98104",{"type":44,"coordinates":74},[75,76],-122.33207,47.60621,{"lat":76,"lon":75},{"facility":79,"status":34,"city":80,"state":34,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":88,"contacts":34},"University of Calgary Liver Unit","Calgary","T2N4Z6","Canada","CA",{"type":44,"coordinates":85},[86,87],-114.08529,51.05011,{"lat":87,"lon":86},{"facility":90,"status":34,"city":91,"state":34,"zip":92,"country":82,"countryCode":83,"cosmosGeoPoint":93,"geoPoint":97,"contacts":34},"Centre de Recherche du Centre Hospitalier de l'Universite de Montreal","Montreal","H2X 0A9",{"type":44,"coordinates":94},[95,96],-73.58781,45.50884,{"lat":96,"lon":95},{"facility":99,"status":34,"city":100,"state":34,"zip":101,"country":82,"countryCode":83,"cosmosGeoPoint":102,"geoPoint":106,"contacts":34},"University Health Network,Toronto general Hospital,Toronto centre for liver disease","Toronto","M5G 2C4",{"type":44,"coordinates":103},[104,105],-79.39864,43.70643,{"lat":105,"lon":104},{"facility":108,"status":34,"city":100,"state":34,"zip":109,"country":82,"countryCode":83,"cosmosGeoPoint":110,"geoPoint":112,"contacts":34},"Toronto Liver Centre","M6H 3M1",{"type":44,"coordinates":111},[104,105],{"lat":105,"lon":104},{"facility":114,"status":34,"city":115,"state":34,"zip":116,"country":82,"countryCode":83,"cosmosGeoPoint":117,"geoPoint":121,"contacts":34},"(G.I.R.I.) GI Research Institute","Vancouver","V6Z 2K5",{"type":44,"coordinates":118},[119,120],-123.11934,49.24966,{"lat":120,"lon":119},{"facility":123,"status":34,"city":124,"state":125,"zip":34,"country":126,"countryCode":127,"cosmosGeoPoint":128,"geoPoint":132,"contacts":34},"Prince of Wales Hospital","Shatin","NT","Hong Kong","HK",{"type":44,"coordinates":129},[130,131],114.18333,22.38333,{"lat":131,"lon":130},{"facility":134,"status":34,"city":135,"state":34,"zip":34,"country":126,"countryCode":127,"cosmosGeoPoint":136,"geoPoint":139,"contacts":34},"Princess Margaret Hospital","Kowloon",{"type":44,"coordinates":137},[130,138],22.31667,{"lat":138,"lon":130},{"facility":141,"status":34,"city":142,"state":34,"zip":34,"country":126,"countryCode":127,"cosmosGeoPoint":143,"geoPoint":147,"contacts":34},"Alice Ho Miu Ling Nethersole Hospital","Tai Po",{"type":44,"coordinates":144},[145,146],114.16877,22.45007,{"lat":146,"lon":145},{"facility":149,"status":34,"city":150,"state":151,"zip":152,"country":153,"countryCode":154,"cosmosGeoPoint":155,"geoPoint":159,"contacts":34},"U.O. Medicina Generale Epatologia IRCCS Humanitas Centro di Ricerca Traslazionale in Epatologia","Rozzano","Milan","20089","Italy","IT",{"type":44,"coordinates":156},[157,158],9.1559,45.38193,{"lat":158,"lon":157},{"facility":161,"status":34,"city":162,"state":34,"zip":163,"country":153,"countryCode":154,"cosmosGeoPoint":164,"geoPoint":168,"contacts":34},"Dipartimento di Scienze Mediche e Chirurgiche (DIMEC) AOU Policlinico S.Orsola-Malpighi di Bologna","Bologna","40138",{"type":44,"coordinates":165},[166,167],11.33875,44.49381,{"lat":167,"lon":166},{"facility":170,"status":34,"city":151,"state":34,"zip":171,"country":153,"countryCode":154,"cosmosGeoPoint":172,"geoPoint":176,"contacts":34},"UOC Gastroenterol-Epatol.-Fondazione IRCCS Ca Granda","20122",{"type":44,"coordinates":173},[174,175],9.18951,45.46427,{"lat":175,"lon":174},{"facility":178,"status":34,"city":179,"state":180,"zip":181,"country":182,"countryCode":183,"cosmosGeoPoint":184,"geoPoint":188,"contacts":34},"Auckland Clinical Studies","Grafton","Auckland","1010","New Zealand","NZ",{"type":44,"coordinates":185},[186,187],174.76566,-36.86029,{"lat":187,"lon":186},{"facility":190,"status":34,"city":191,"state":34,"zip":192,"country":193,"countryCode":34,"cosmosGeoPoint":194,"geoPoint":198,"contacts":34},"Dong-A University Hospital","Busan","49201","South Korea",{"type":44,"coordinates":195},[196,197],129.03004,35.10168,{"lat":197,"lon":196},{"facility":200,"status":34,"city":191,"state":34,"zip":201,"country":193,"countryCode":34,"cosmosGeoPoint":202,"geoPoint":204,"contacts":34},"Pusan National University Hospital","49241",{"type":44,"coordinates":203},[196,197],{"lat":197,"lon":196},{"facility":206,"status":34,"city":207,"state":34,"zip":208,"country":193,"countryCode":34,"cosmosGeoPoint":209,"geoPoint":213,"contacts":34},"Asan Medical Center","Seoul","05505",{"type":44,"coordinates":210},[211,212],126.9784,37.566,{"lat":212,"lon":211},{"facility":215,"status":34,"city":207,"state":34,"zip":216,"country":193,"countryCode":34,"cosmosGeoPoint":217,"geoPoint":219,"contacts":34},"Yonsei University Health System, Severance Hospital","120-752",{"type":44,"coordinates":218},[211,212],{"lat":212,"lon":211},{"facility":221,"status":34,"city":222,"state":34,"zip":223,"country":224,"countryCode":225,"cosmosGeoPoint":226,"geoPoint":230,"contacts":34},"Changhua Christian Hospital","Changhua","500","Taiwan","TW",{"type":44,"coordinates":227},[228,229],120.5512,24.0692,{"lat":229,"lon":228},{"facility":232,"status":34,"city":233,"state":34,"zip":234,"country":224,"countryCode":225,"cosmosGeoPoint":235,"geoPoint":239,"contacts":34},"Ditmanson Medical Foundation Chia-Yi Christian Hospital","Chiayi City","60002",{"type":44,"coordinates":236},[237,238],120.44889,23.47917,{"lat":238,"lon":237},{"facility":241,"status":34,"city":242,"state":34,"zip":243,"country":224,"countryCode":225,"cosmosGeoPoint":244,"geoPoint":248,"contacts":34},"Kaohsiung Medical University Chung-Ho Memorial Hospital","Kaohsiung City","807",{"type":44,"coordinates":245},[246,247],120.31333,22.61626,{"lat":247,"lon":246},{"facility":250,"status":34,"city":242,"state":34,"zip":251,"country":224,"countryCode":225,"cosmosGeoPoint":252,"geoPoint":254,"contacts":34},"Kaohsiung Chang Gung Memorial Hospital","83301",{"type":44,"coordinates":253},[246,247],{"lat":247,"lon":246},{"facility":256,"status":34,"city":257,"state":34,"zip":258,"country":224,"countryCode":225,"cosmosGeoPoint":259,"geoPoint":263,"contacts":34},"Taichung Veterans Genl Hosp","Taichung","40705",{"type":44,"coordinates":260},[261,262],120.6839,24.1469,{"lat":262,"lon":261},{"facility":265,"status":34,"city":266,"state":34,"zip":267,"country":224,"countryCode":225,"cosmosGeoPoint":268,"geoPoint":272,"contacts":34},"National Taiwan University Hospital","Taipei","10001",{"type":44,"coordinates":269},[270,271],121.52639,25.05306,{"lat":271,"lon":270},{"facility":274,"status":34,"city":266,"state":34,"zip":275,"country":224,"countryCode":225,"cosmosGeoPoint":276,"geoPoint":278,"contacts":34},"Veterans General Hospital-Taipei","11217",{"type":44,"coordinates":277},[270,271],{"lat":271,"lon":270},{"facility":280,"status":34,"city":281,"state":34,"zip":282,"country":224,"countryCode":225,"cosmosGeoPoint":283,"geoPoint":287,"contacts":34},"Chang Gung Medical Foundation, Linkou Chang Gung Memorial Hospital","Taoyuan City","333",{"type":44,"coordinates":284},[285,286],121.29696,24.99368,{"lat":286,"lon":285},{"facility":289,"status":34,"city":290,"state":34,"zip":291,"country":292,"countryCode":293,"cosmosGeoPoint":294,"geoPoint":298,"contacts":34},"Nottingham University Hospital","London","NG7 2UH","United Kingdom","UK",{"type":44,"coordinates":295},[296,297],-0.12574,51.50853,{"lat":297,"lon":296},{"facility":300,"status":34,"city":290,"state":34,"zip":301,"country":292,"countryCode":293,"cosmosGeoPoint":302,"geoPoint":304,"contacts":34},"King's College Hospital NHS Foundation Trust","SE5 9RS",{"type":44,"coordinates":303},[296,297],{"lat":297,"lon":296},{"type":306,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100299635","phase-2-study-to-evaluate-the-safety-and-efficacy-of-switching-to-tenofovir-alafenamide-taf-from-tenofovir-disoproxil-fumarate-tdf-andor-other-oral-antiviral-treatment-oav-100299635",true,"NCT03180619","Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and\u002For Other Oral Antiviral Treatment (OAV)","A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and\u002For Other Oral Antiviral Treatment (OAV) in Virologically Suppressed Chronic Hepatitis B Subjects With Renal and\u002For Hepatic Impairment","Key Inclusion Criteria:\n\nAll Participants (Parts A and B):\n\n* Adult male or non-pregnant female individuals\n* Documented evidence of chronic HBV infection\n* Alanine aminotransferase (ALT) ≤ 10 × upper limit of normal (ULN)\n\nPart A Only (renal impairment):\n\n* Maintained on TDF and\u002For other OAV treatment(s) for CHB for at least 48 weeks and with viral suppression (HBV deoxyribonucleic acid \\[DNA\\] \\\u003C lower limit of quantitation \\[LLOQ\\]) for ≥ 6 months prior to screening\n\n  * All individuals must have HBV DNA \\\u003C 20 International units per milliliter (IU\u002FmL) at screening by central laboratory\n  * Both Hepatitis B e-Antigen (HBeAg) positive and negative individuals are eligible to participate\n* Moderate renal impairment (30 milliliters per minute \\[mL\u002Fmin\\] ≤ estimated glomerular filtration rate by the cockcroft-gault formula \\[eGFRcg\\] ≤ 59 mL\u002Fmin), severe renal impairment (15 mL\u002Fmin ≤ eGFRcg \\\u003C 30 mL\u002Fmin) or end stage renal disease (ESRD) (eGFR \\\u003C 15 mL\u002Fmin) maintained on hemodialysis (HD)\n* Stable renal function (for participants with moderate or severe impairment): serum creatinine measured at least once within three months prior to screening. The measurement difference between the value measured within three months prior to screening versus the screening value must be ≤ 25% of the screening value\n\nPart B Only (hepatic impairment):\n\n* Maintained on TDF and\u002For other OAV(s) for CHB for at least 48 weeks and with viral suppression (HBV DNA \\\u003C LLOQ) for ≥ 6 months prior to screening\n\n  * All individuals must have HBV DNA \\\u003C 20 IU\u002FmL at screening by central laboratory\n  * Both HBeAg positive and negative individuals are eligible to participate\n* Child-pugh-turcotte (CPT) score of 7-12 (inclusive) OR a past history of CPT score ≥ 7 and any CPT score ≤ 12 at screening\n* eGFRCG ≥ 30 mL\u002Fmin using the Cockcroft-Gault equation\n\nKey Exclusion Criteria:\n\nAll Individuals (Parts A \\& B):\n\n* Women who are breastfeeding or who believe they may wish to become pregnant during the course of the study\n* Males and females of reproductive potential who are unwilling to use an \"effective\", protocol-specified method(s) of contraception during the study\n* Co-infection with hepatitis C virus (HCV), human immunodeficiency virus (HIV), or hepatitis D virus (HDV)\n* Prior Interferon (IFN) use within 6 months of screening\n* Evidence of hepatocellular carcinoma\n* Received solid organ or bone marrow transplant\n* Significant cardiovascular, pulmonary, or neurological disease\n* Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Individuals under evaluation for possible malignancy are not eligible\n* Currently receiving therapy with immunomodulators (e.g. corticosteroids), nephrotoxic agents, or agents capable of modifying renal excretion\n* Known hypersensitivity to study drugs, metabolites, or formulation excipients\n* Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance\n* Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements.\n\nPart A Only (Renal Impairment):\n\n* Current or historical evidence of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)\n* Abnormal hematological and biochemical parameters, including:\n\n  * Hemoglobin \\\u003C 9 grams per deciliter (g\u002FdL)\n  * Absolute neutrophil count \\\u003C 750\u002Fcubic millimeter (mm\\^3)\n  * Platelets ≤ 50,000\u002Fmm\\^3\n  * Aspartate aminotransferase (AST) \\> 10 × ULN\n  * Albumin \\\u003C 3.0 g\u002FdL\n  * Total bilirubin \\> 2.5 × ULN\n  * International normalized ratio of prothrombin time (INR) \\> 1.5 × ULN (unless stable on anticoagulant regimen)\n* Individuals with ESRD (i.e. eGFRcg \\\u003C 15 mL\u002Fmin) not on HD, or those on other forms of renal replacement therapy (i.e. peritoneal dialysis)\n\nPart B Only (Hepatic Impairment):\n\n* Active variceal bleeding within 6 months or prior placement of a portosystemic shunt (such as transjugular intrahepatic portosystemic shunt \\[TIPS\\])\n* History of hepatorenal syndrome, hepatopulmonary syndrome, Grade 3 or Grade 4 hepatic encephalopathy, or spontaneous bacterial peritonitis within 6 months of screening\n* Grade 2 hepatic encephalopathy at screening\n* Model for end-stage liver disease (MELD) score ≥ 30\n* Abnormal hematological and biochemical parameters, including\n\n  * Absolute neutrophil count \\\u003C 750\u002Fmm\\^3\n  * Platelets \\\u003C 30,000\u002Fmm\\^3\n  * Hemoglobin \\\u003C 8.0 g\u002FdL\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",false,"ALL","18 Years",{"count":318,"type":319},124,"ACTUAL","INTERVENTIONAL",[322],"PHASE2","The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and\u002For hepatic impairment.",[325],"Chronic Hepatitis B","COMPLETED","2021-08-30",{"date":329,"type":319},"2021-09-27",{"date":331,"type":319},"2017-06-29",{"date":333,"type":319},"2020-09-04",{"name":5,"class":6},30]