[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100222522":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":43,"centralContacts":42,"locations":47,"responsibleParty":310,"collaborators":42,"id":312,"slug":313,"hasResults":314,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":42,"eligibilityCriteria":318,"healthyVolunteers":319,"sex":320,"minAge":321,"maxAge":42,"enrollmentInfo":322,"targetDuration":42,"studyType":325,"phases":326,"briefSummary":328,"conditions":329,"keywords":42,"overallStatus":331,"whyStopped":42,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":340},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"TDF 48 weeks","ACTIVE_COMPARATOR","Participants will receive TDF for 48 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks.",[13],"Drug: Tenofovir disoproxil fumarate",{"label":15,"type":16,"description":17,"interventionNames":18},"TDF plus GS-4774 2 YU","EXPERIMENTAL","Participants will receive TDF plus GS-4774 2 yeast units (YU) for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks.",[13,19],"Biological: GS-4774",{"label":21,"type":16,"description":22,"interventionNames":23},"TDF plus GS-4774 10 YU","Participants will receive TDF plus GS-4774 10 YU for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks.",[13,19],{"label":25,"type":16,"description":26,"interventionNames":27},"TDF plus GS-4774 40 YU","Participants will receive TDF plus GS-4774 40 YU for 20 weeks. After Week 20, GS-4774 will be discontinued and participants will continue on TDF for an additional 28 weeks. After Week 48, participants will have the option to continue receiving TDF for up to 144 weeks.",[13,19],[29,37],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","Tenofovir disoproxil fumarate","TDF 300 mg tablet administered orally once daily",[9,21,15,25],[35,36],"TDF","Viread®",{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"BIOLOGICAL","GS-4774","GS-4774 subcutaneous injection administered every 4 weeks for a total of 6 doses",[21,15,25],null,[44],{"name":45,"affiliation":5,"role":46},"Gilead Study Director","STUDY_DIRECTOR",[48,60,68,76,84,92,101,110,119,127,136,145,152,163,168,177,186,191,196,206,214,222,230,240,250,255,264,272,280,288,293,298,306],{"facility":49,"status":42,"city":50,"state":51,"zip":42,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":42},"Stanford University Medical Center","Palo Alto","California","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-122.14302,37.44188,{"lat":58,"lon":57},{"facility":61,"status":42,"city":62,"state":51,"zip":42,"country":52,"countryCode":53,"cosmosGeoPoint":63,"geoPoint":67,"contacts":42},"Kaiser Permanente","Sacramento",{"type":55,"coordinates":64},[65,66],-121.4944,38.58157,{"lat":66,"lon":65},{"facility":69,"status":42,"city":70,"state":51,"zip":42,"country":52,"countryCode":53,"cosmosGeoPoint":71,"geoPoint":75,"contacts":42},"Research and Education, Inc.","San Diego",{"type":55,"coordinates":72},[73,74],-117.16472,32.71571,{"lat":74,"lon":73},{"facility":77,"status":42,"city":78,"state":51,"zip":42,"country":52,"countryCode":53,"cosmosGeoPoint":79,"geoPoint":83,"contacts":42},"Kaiser Permanente San Francisco","San Francisco",{"type":55,"coordinates":80},[81,82],-122.41942,37.77493,{"lat":82,"lon":81},{"facility":85,"status":42,"city":86,"state":51,"zip":42,"country":52,"countryCode":53,"cosmosGeoPoint":87,"geoPoint":91,"contacts":42},"Silicon Valley Research Institute","San Jose",{"type":55,"coordinates":88},[89,90],-121.89496,37.33939,{"lat":90,"lon":89},{"facility":93,"status":42,"city":94,"state":95,"zip":42,"country":52,"countryCode":53,"cosmosGeoPoint":96,"geoPoint":100,"contacts":42},"The Queen's Medical Center","Honolulu","Hawaii",{"type":55,"coordinates":97},[98,99],-157.85833,21.30694,{"lat":99,"lon":98},{"facility":102,"status":42,"city":103,"state":104,"zip":42,"country":52,"countryCode":53,"cosmosGeoPoint":105,"geoPoint":109,"contacts":42},"Digestive Disease Associates, PA","Baltimore","Maryland",{"type":55,"coordinates":106},[107,108],-76.61219,39.29038,{"lat":108,"lon":107},{"facility":111,"status":42,"city":112,"state":113,"zip":42,"country":52,"countryCode":53,"cosmosGeoPoint":114,"geoPoint":118,"contacts":42},"Tufts Medical Center","Boston","Massachusetts",{"type":55,"coordinates":115},[116,117],-71.05977,42.35843,{"lat":117,"lon":116},{"facility":120,"status":42,"city":121,"state":121,"zip":42,"country":52,"countryCode":53,"cosmosGeoPoint":122,"geoPoint":126,"contacts":42},"Icahn School of Medicine at Mount Sinai","New York",{"type":55,"coordinates":123},[124,125],-74.00597,40.71427,{"lat":125,"lon":124},{"facility":128,"status":42,"city":129,"state":130,"zip":42,"country":52,"countryCode":53,"cosmosGeoPoint":131,"geoPoint":135,"contacts":42},"Xiaoli Ma, PC","Philadelphia","Pennsylvania",{"type":55,"coordinates":132},[133,134],-75.16362,39.95238,{"lat":134,"lon":133},{"facility":137,"status":42,"city":138,"state":139,"zip":42,"country":52,"countryCode":53,"cosmosGeoPoint":140,"geoPoint":144,"contacts":42},"Virginia Commonwealth University","Richmond","Virginia",{"type":55,"coordinates":141},[142,143],-77.46026,37.55376,{"lat":143,"lon":142},{"facility":61,"status":42,"city":146,"state":139,"zip":42,"country":52,"countryCode":53,"cosmosGeoPoint":147,"geoPoint":151,"contacts":42},"Springfield",{"type":55,"coordinates":148},[149,150],-77.1872,38.78928,{"lat":150,"lon":149},{"facility":153,"status":42,"city":154,"state":155,"zip":42,"country":156,"countryCode":157,"cosmosGeoPoint":158,"geoPoint":162,"contacts":42},"Gordon & Leslie Diamond Health Care Centre","Vancouver","British Columbia","Canada","CA",{"type":55,"coordinates":159},[160,161],-123.11934,49.24966,{"lat":161,"lon":160},{"facility":164,"status":42,"city":154,"state":155,"zip":42,"country":156,"countryCode":157,"cosmosGeoPoint":165,"geoPoint":167,"contacts":42},"Liver and Intestinal Research Center",{"type":55,"coordinates":166},[160,161],{"lat":161,"lon":160},{"facility":169,"status":42,"city":170,"state":171,"zip":42,"country":156,"countryCode":157,"cosmosGeoPoint":172,"geoPoint":176,"contacts":42},"University of Manitoba","Winnipeg","Manitoba",{"type":55,"coordinates":173},[174,175],-97.14704,49.8844,{"lat":175,"lon":174},{"facility":178,"status":42,"city":179,"state":180,"zip":42,"country":156,"countryCode":157,"cosmosGeoPoint":181,"geoPoint":185,"contacts":42},"Toronto General Hospital-The University Health Network","Toronto","Ontario",{"type":55,"coordinates":182},[183,184],-79.39864,43.70643,{"lat":184,"lon":183},{"facility":187,"status":42,"city":179,"state":180,"zip":42,"country":156,"countryCode":157,"cosmosGeoPoint":188,"geoPoint":190,"contacts":42},"Toronto Liver Centre",{"type":55,"coordinates":189},[183,184],{"lat":184,"lon":183},{"facility":192,"status":42,"city":179,"state":180,"zip":42,"country":156,"countryCode":157,"cosmosGeoPoint":193,"geoPoint":195,"contacts":42},"Toronto Western Hospital-The University Health Network",{"type":55,"coordinates":194},[183,184],{"lat":184,"lon":183},{"facility":197,"status":42,"city":198,"state":42,"zip":42,"country":199,"countryCode":200,"cosmosGeoPoint":201,"geoPoint":205,"contacts":42},"Aou-S.Orsola-Malpighi - Universita Degli Studi Di","Bologna","Italy","IT",{"type":55,"coordinates":202},[203,204],11.33875,44.49381,{"lat":204,"lon":203},{"facility":207,"status":42,"city":208,"state":42,"zip":42,"country":199,"countryCode":200,"cosmosGeoPoint":209,"geoPoint":213,"contacts":42},"Azienda Ospedaliero-Universitaria di Parma","Parma",{"type":55,"coordinates":210},[211,212],10.32618,44.79935,{"lat":212,"lon":211},{"facility":215,"status":42,"city":216,"state":42,"zip":42,"country":199,"countryCode":200,"cosmosGeoPoint":217,"geoPoint":221,"contacts":42},"Azienda Ospedaliero-Universitaria Pisana","Pisa",{"type":55,"coordinates":218},[219,220],10.4036,43.70853,{"lat":220,"lon":219},{"facility":223,"status":42,"city":224,"state":42,"zip":42,"country":199,"countryCode":200,"cosmosGeoPoint":225,"geoPoint":229,"contacts":42},"IRCCS Casa Sollievo della Sofferenza","San Giovanni Rotondo",{"type":55,"coordinates":226},[227,228],15.7277,41.70643,{"lat":228,"lon":227},{"facility":231,"status":42,"city":232,"state":42,"zip":42,"country":233,"countryCode":234,"cosmosGeoPoint":235,"geoPoint":239,"contacts":42},"Auckland Clinical Studies","Auckland","New Zealand","NZ",{"type":55,"coordinates":236},[237,238],174.76349,-36.84853,{"lat":238,"lon":237},{"facility":241,"status":42,"city":242,"state":42,"zip":42,"country":243,"countryCode":244,"cosmosGeoPoint":245,"geoPoint":249,"contacts":42},"Dr. Victor Babes Hospital for Infectious Diseases","Bucharest","Romania","RO",{"type":55,"coordinates":246},[247,248],26.10626,44.43225,{"lat":248,"lon":247},{"facility":251,"status":42,"city":242,"state":42,"zip":42,"country":243,"countryCode":244,"cosmosGeoPoint":252,"geoPoint":254,"contacts":42},"Institutul National de Boli Infectioase Prof.Dr. Matei Bals",{"type":55,"coordinates":253},[247,248],{"lat":248,"lon":247},{"facility":256,"status":42,"city":257,"state":42,"zip":42,"country":258,"countryCode":42,"cosmosGeoPoint":259,"geoPoint":263,"contacts":42},"Kyungpook National University Hospital","Daegu","South Korea",{"type":55,"coordinates":260},[261,262],128.59111,35.87028,{"lat":262,"lon":261},{"facility":265,"status":42,"city":266,"state":42,"zip":42,"country":258,"countryCode":42,"cosmosGeoPoint":267,"geoPoint":271,"contacts":42},"The Catholic University of Korea","Seocho",{"type":55,"coordinates":268},[269,270],127.02,37.49056,{"lat":270,"lon":269},{"facility":273,"status":42,"city":274,"state":42,"zip":42,"country":258,"countryCode":42,"cosmosGeoPoint":275,"geoPoint":279,"contacts":42},"Seoul National University Bundang Hospital","Seongnam",{"type":55,"coordinates":276},[277,278],127.7548,36.4052,{"lat":278,"lon":277},{"facility":281,"status":42,"city":282,"state":42,"zip":42,"country":258,"countryCode":42,"cosmosGeoPoint":283,"geoPoint":287,"contacts":42},"Samsung Medical Center","Seoul",{"type":55,"coordinates":284},[285,286],126.9784,37.566,{"lat":286,"lon":285},{"facility":289,"status":42,"city":282,"state":42,"zip":42,"country":258,"countryCode":42,"cosmosGeoPoint":290,"geoPoint":292,"contacts":42},"Seoul National University College of Medicine",{"type":55,"coordinates":291},[285,286],{"lat":286,"lon":285},{"facility":294,"status":42,"city":282,"state":42,"zip":42,"country":258,"countryCode":42,"cosmosGeoPoint":295,"geoPoint":297,"contacts":42},"Yonsei Universiity",{"type":55,"coordinates":296},[285,286],{"lat":286,"lon":285},{"facility":299,"status":42,"city":300,"state":42,"zip":42,"country":258,"countryCode":42,"cosmosGeoPoint":301,"geoPoint":305,"contacts":42},"Pusan National University Yangsan Hospital","Yangsan",{"type":55,"coordinates":302},[303,304],129.03358,35.34199,{"lat":304,"lon":303},{"facility":265,"status":42,"city":300,"state":42,"zip":42,"country":258,"countryCode":42,"cosmosGeoPoint":307,"geoPoint":309,"contacts":42},{"type":55,"coordinates":308},[303,304],{"lat":304,"lon":303},{"type":311,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100222522","phase-2-safety-and-efficacy-of-gs-4774-in-combination-with-tenofovir-disoproxil-fumarate-tdf-for-the-treatment-of-participants-with-chronic-hepatitis-b-chb-and-who-are-currently-not-on-treatment-100222522",true,"NCT02174276","Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment","A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment","Key Inclusion Criteria:\n\n* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study\n* Documented evidence of chronic hepatitis B virus (HBV) infection, for example, hepatitis B surface antigen (HBsAg) positive for more than 6 months\n* Screening HBV DNA ≥ 2000 IU\u002FmL\n* A negative serum pregnancy test is required for females (unless surgically sterile or \\> 2 years post-menopausal)\n\nKey Exclusion Criteria:\n\n* Cirrhosis\n* Inadequate liver function\n* Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)\n* Received antiviral treatment for HBV within 3 months of screening\n* Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)\n* Significant cardiovascular, pulmonary, or neurological disease\n* Women who are pregnant or may wish to become pregnant during the course of the study\n* Received solid organ or bone marrow transplant\n* Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening\n* Use of investigational agents within 3 months of screening\n* Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance\n* Receipt of immunoglobulin or other blood products within 3 months prior to enrollment\n* History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease\n* Documented history of yeast allergy\n* Known hypersensitivity to study drugs, metabolites or formulation excipients\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\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",false,"ALL","18 Years",{"count":323,"type":324},195,"ACTUAL","INTERVENTIONAL",[327],"PHASE2","The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of GS-4774 in adults with CHB and who are currently not on treatment. Participants will be randomized to receive TDF alone or GS-4774 plus TDF for 20 weeks. After Week 20, GS-4774 will be discontinued. All participants will continue on TDF and will be followed for an additional 28 weeks. Following completion of the 48 week study period, all participants will be eligible for a treatment extension for 96 weeks.",[330],"Chronic Hepatitis B","COMPLETED","2019-05-15",{"date":334,"type":324},"2019-06-04",{"date":336,"type":324},"2014-07-24",{"date":338,"type":324},"2018-05-30",{"name":5,"class":6},33]