[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100600338":3},{"organization":4,"outcomesModule":7,"designInfo":68,"detailedDescription":11,"studyPopulation":11,"armGroups":77,"interventions":94,"overallOfficials":106,"centralContacts":110,"locations":116,"responsibleParty":281,"collaborators":11,"id":283,"slug":284,"hasResults":285,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":11,"eligibilityCriteria":289,"healthyVolunteers":290,"sex":291,"minAge":292,"maxAge":293,"enrollmentInfo":294,"targetDuration":11,"studyType":297,"phases":298,"briefSummary":301,"conditions":302,"keywords":11,"overallStatus":119,"whyStopped":11,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":313},{"fullName":5,"class":6},"Gilead Sciences","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":33,"otherOutcomes":11},[9,13,15,17,21,24,27,29],{"measure":10,"description":11,"timeFrame":12},"Phase 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events",null,"Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up",{"measure":14,"description":11,"timeFrame":12},"Phase 1 and 2: Percentage of Participants With Treatment-emergent Serious Adverse Events",{"measure":16,"description":11,"timeFrame":12},"Phase 1 and 2: Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities",{"measure":18,"description":19,"timeFrame":20},"Phase 1: Serum Pharmacokinetic (PK) parameter; AUC of GS-4321","AUC is defined as the area under the concentration versus time curve","First dose up to 24 Weeks",{"measure":22,"description":23,"timeFrame":20},"Phase 1: Serum PK Parameter: Cmax","Cmax is defined as the maximum observed concentration of drug.",{"measure":25,"description":26,"timeFrame":20},"Phase 1: Serum PK Parameter: Tmax","Tmax is defined as the time (observed time point) of Cmax.",{"measure":28,"description":11,"timeFrame":20},"Phase 1: Serum PK Parameter: t1\u002F2",{"measure":30,"description":31,"timeFrame":32},"Phase 2: Proportion of Participants with Combined Response","Combined Response is defined as undetectable hepatitis delta virus (HDV) RNA or ≥ 2 log10 decrease in HDV RNA from baseline and normal alanine aminotransferase (ALT) normalization (ALT \\\u003C upper limit of normal (ULN) at week 24).","Up to 96 Weeks",[34,37,40,42,44,46,49,52,55,58,61,63,66],{"measure":35,"description":36,"timeFrame":20},"Phase 1: Proportion of Participants who Develop Antidrug Antibody (ADAs) After Administration of a Single Dose of GS-4321 and ADA Titer Characterization","ADA Titer characterization will include proportion of participants with ADA incidence, prevalence, persistence, and transience .",{"measure":38,"description":11,"timeFrame":39},"Phase 2: Serum PK Parameters AUC of GS-4321","Up to 96 weeks",{"measure":41,"description":11,"timeFrame":32},"Phase 2: Serum PK Parameters Cmax of GS-4321",{"measure":43,"description":11,"timeFrame":32},"Phase 2: Serum PK Parameters Tmax of GS-4321",{"measure":45,"description":11,"timeFrame":32},"Phase 2: Serum PK Parameters Ctrough of GS-4321",{"measure":47,"description":11,"timeFrame":48},"Phase 2: Proportion of Participants With Undetectable HDV RNA or ≥ 2 log10 Decrease in HDV RNA From Baseline and normal ALT (ALT \u003C ULN).","Weeks 4, 8, 12, 16, 20, 36, 48, 60, 72, 84, and 96",{"measure":50,"description":11,"timeFrame":51},"Phase 2: Change From Baseline in HDV RNA","Baseline, Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96",{"measure":53,"description":11,"timeFrame":54},"Phase 2: Proportion of Participants With Undetectable HDV RNA","Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96",{"measure":56,"description":11,"timeFrame":57},"Proportion of Participants With undetectable HDV RNA or ≥ 2 log10 Decrease in HDV From Baseline","Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84 and 96",{"measure":59,"description":11,"timeFrame":60},"Phase 2: Change From Baseline in Liver Stiffness by Elastography","Weeks 24, 48, and 96",{"measure":62,"description":11,"timeFrame":54},"Phase 2: Proportion of Participants with normal ALT",{"measure":64,"description":36,"timeFrame":65},"Phase 2: Proportion of Participants who Develop ADAs After Administration of Multiple Doses of GS-4321 and ADA Titer Characterization","First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up",{"measure":67,"description":11,"timeFrame":65},"Phase 2: Characterize if Emergent Variants are Associated With Reduced Susceptibility to GS-4321 in Vitro and Virologic Failure in Participants With CHD",{"allocation":69,"interventionModel":70,"interventionModelDescription":11,"primaryPurpose":71,"observationalModel":11,"timePerspective":11,"maskingInfo":72},"NON_RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":73,"maskingDescription":11,"whoMasked":74},"DOUBLE",[75,76],"PARTICIPANT","INVESTIGATOR",[78,84,90],{"label":79,"type":80,"description":81,"interventionNames":82},"Phase 1: GS-4321","EXPERIMENTAL","Participants will receive single escalating doses of GS-4321.",[83],"Drug: GS-4321",{"label":85,"type":86,"description":87,"interventionNames":88},"Phase 1: Placebo","PLACEBO_COMPARATOR","Participants will receive placebo to match the single escalating doses of GS-4321",[89],"Drug: GS-4321 Placebo",{"label":91,"type":80,"description":92,"interventionNames":93},"Phase 2: GS-4321","Participants will receive multiple escalating doses of GS-4321 up to 96 weeks.",[83],[95,100,104],{"type":96,"name":97,"description":98,"armGroupLabels":99,"otherNames":11},"DRUG","GS-4321","Administered subcutaneous (SC) or intravenously IV",[79],{"type":96,"name":101,"description":102,"armGroupLabels":103,"otherNames":11},"GS-4321 Placebo","Administered SC",[85],{"type":96,"name":97,"description":102,"armGroupLabels":105,"otherNames":11},[91],[107],{"name":108,"affiliation":5,"role":109},"Gilead Study Director","STUDY_DIRECTOR",[111],{"name":112,"role":113,"phone":114,"phoneExt":11,"email":115},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",[117,131,141,151,160,171,177,184,190,201,207,213,222,232,241,250,256,266,275],{"facility":118,"status":119,"city":120,"state":121,"zip":122,"country":123,"countryCode":124,"cosmosGeoPoint":125,"geoPoint":130,"contacts":11},"Investigative Site","RECRUITING","Anaheim","California","92801","United States","US",{"type":126,"coordinates":127},"Point",[128,129],-117.9145,33.83529,{"lat":129,"lon":128},{"facility":132,"status":119,"city":133,"state":134,"zip":135,"country":123,"countryCode":124,"cosmosGeoPoint":136,"geoPoint":140,"contacts":11},"University of Louisville, Clinical Trials Unit","Louisville","Kentucky","40202",{"type":126,"coordinates":137},[138,139],-85.75941,38.25424,{"lat":139,"lon":138},{"facility":142,"status":119,"city":143,"state":144,"zip":145,"country":123,"countryCode":124,"cosmosGeoPoint":146,"geoPoint":150,"contacts":11},"University of Maryland, Institute of Human Virology, Clinical Research Unit","Baltimore","Maryland","21201",{"type":126,"coordinates":147},[148,149],-76.61219,39.29038,{"lat":149,"lon":148},{"facility":152,"status":119,"city":153,"state":153,"zip":154,"country":123,"countryCode":124,"cosmosGeoPoint":155,"geoPoint":159,"contacts":11},"The New York-Presbyterian Hospital","New York","10021",{"type":126,"coordinates":156},[157,158],-74.00597,40.71427,{"lat":158,"lon":157},{"facility":161,"status":119,"city":162,"state":11,"zip":163,"country":164,"countryCode":165,"cosmosGeoPoint":166,"geoPoint":170,"contacts":11},"Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, SC Gastroenterologia ed Epatologia","Milan","882","Italy","IT",{"type":126,"coordinates":167},[168,169],12.59836,42.78235,{"lat":169,"lon":168},{"facility":172,"status":119,"city":173,"state":11,"zip":174,"country":175,"countryCode":176,"cosmosGeoPoint":11,"geoPoint":11,"contacts":11},"IMSP Spitalul Clinic de Boli Infectioase \"Toma Ciorba\"","Chinsinau","2004","Moldova","MD",{"facility":172,"status":119,"city":178,"state":11,"zip":174,"country":175,"countryCode":176,"cosmosGeoPoint":179,"geoPoint":183,"contacts":11},"Chisinau",{"type":126,"coordinates":180},[181,182],28.85938,47.00902,{"lat":182,"lon":181},{"facility":185,"status":119,"city":178,"state":11,"zip":186,"country":175,"countryCode":176,"cosmosGeoPoint":187,"geoPoint":189,"contacts":11},"PMSI Clinical Republican Hospital \"Timofei Mosneaga\"","MD-2025",{"type":126,"coordinates":188},[181,182],{"lat":182,"lon":181},{"facility":191,"status":119,"city":192,"state":11,"zip":193,"country":194,"countryCode":195,"cosmosGeoPoint":196,"geoPoint":200,"contacts":11},"Institutul National De Boli Infectioase Prof. Dr. Matei Bals","Bucharest","021105","Romania","RO",{"type":126,"coordinates":197},[198,199],26.10626,44.43225,{"lat":199,"lon":198},{"facility":202,"status":119,"city":192,"state":11,"zip":203,"country":194,"countryCode":195,"cosmosGeoPoint":204,"geoPoint":206,"contacts":11},"Fundatia Dr. Victor Babes","030303",{"type":126,"coordinates":205},[198,199],{"lat":199,"lon":198},{"facility":208,"status":119,"city":192,"state":11,"zip":209,"country":194,"countryCode":195,"cosmosGeoPoint":210,"geoPoint":212,"contacts":11},"Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals","21105",{"type":126,"coordinates":211},[198,199],{"lat":199,"lon":198},{"facility":214,"status":119,"city":215,"state":11,"zip":216,"country":194,"countryCode":195,"cosmosGeoPoint":217,"geoPoint":221,"contacts":11},"Gastromedica S.R.L.","Iași","700506",{"type":126,"coordinates":218},[219,220],27.6,47.16667,{"lat":220,"lon":219},{"facility":223,"status":119,"city":224,"state":11,"zip":225,"country":226,"countryCode":11,"cosmosGeoPoint":227,"geoPoint":231,"contacts":11},"Korea University Ansan Hospital","Ansan-si","425-707","South Korea",{"type":126,"coordinates":228},[229,230],126.82194,37.32361,{"lat":230,"lon":229},{"facility":233,"status":119,"city":234,"state":11,"zip":235,"country":226,"countryCode":11,"cosmosGeoPoint":236,"geoPoint":240,"contacts":11},"The Catholic University of Korea Bucheon St. Mary's Hospital","Bucheon-si","14647",{"type":126,"coordinates":237},[238,239],126.78306,37.49889,{"lat":239,"lon":238},{"facility":242,"status":119,"city":243,"state":11,"zip":244,"country":226,"countryCode":11,"cosmosGeoPoint":245,"geoPoint":249,"contacts":11},"The Catholic University of Korea, Seoul St. Mary's Hospital","Seoul","06591",{"type":126,"coordinates":246},[247,248],126.9784,37.566,{"lat":248,"lon":247},{"facility":251,"status":119,"city":243,"state":11,"zip":252,"country":226,"countryCode":11,"cosmosGeoPoint":253,"geoPoint":255,"contacts":11},"Samsung Medical Center","135-710",{"type":126,"coordinates":254},[247,248],{"lat":248,"lon":247},{"facility":257,"status":119,"city":258,"state":11,"zip":11,"country":259,"countryCode":260,"cosmosGeoPoint":261,"geoPoint":265,"contacts":11},"Ditmanson Medical Foundation Chia-Yi Christian Hospital","Chiayi City","Taiwan","TW",{"type":126,"coordinates":262},[263,264],120.44889,23.47917,{"lat":264,"lon":263},{"facility":267,"status":119,"city":268,"state":11,"zip":269,"country":259,"countryCode":260,"cosmosGeoPoint":270,"geoPoint":274,"contacts":11},"Kaohsiung Medical University Chung-Ho Memorial Hospital","Kaohsiung City","807",{"type":126,"coordinates":271},[272,273],120.31333,22.61626,{"lat":273,"lon":272},{"facility":276,"status":119,"city":268,"state":11,"zip":277,"country":259,"countryCode":260,"cosmosGeoPoint":278,"geoPoint":280,"contacts":11},"Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital","83301",{"type":126,"coordinates":279},[272,273],{"lat":273,"lon":272},{"type":282,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100600338","phase-1-study-of-gs-4321-in-healthy-participants-and-participants-with-chronic-hepatitis-delta-virus-100600338",false,"NCT07096193","Study of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta Virus","Phase 1\u002F2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta","Key Inclusion Criteria:\n\nPart A:\n\n* Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.\n* Have a body mass index (BMI) of ≤ 30.0 kg\u002Fm2 at screening and at admission.\n\nPart B:\n\n* Participants assigned male or female at birth who are of childbearing potential and engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.\n* Chronic hepatitis delta (CHD) for ≥ 6 months prior to screening, documented by prior medical history.\n* Must be receiving a commercially available entecavir, TAF, or TDF for the treatment of hepatitis B virus (HBV) infection at or prior to enrollment. Coformulation as part of a fixed-dose combination for the treatment of HIV is permitted.\n* Non-cirrhotic or compensated cirrhosis.\n* Hepatitis delta virus ribonucleic acid (HDV RNA ) \\> 500 IU\u002FmL at screening.\n* Alanine aminotransferase (ALT) level \\> 1 × Upper limit of normal (ULN), but \\\u003C 10 × ULN at screening.\n\nKey Exclusion Criteria:\n\nPart A:\n\n* Positive serum or urine pregnancy test.\n* Participants with plans to breastfeed during the study period.\n\nPart B:\n\n* Positive serum or urine pregnancy test.\n* Participants with plans to breastfeed during the study period.\n* Current or previous clinically decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage due to HDV or HBV.\n* Child-Turcotte-Pugh (CTP)-B or -C or a CTP score of ≥ 7.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply.",true,"ALL","18 Years","69 Years",{"count":295,"type":296},200,"ESTIMATED","INTERVENTIONAL",[299,300],"PHASE1","PHASE2","The goals of this clinical study are to first learn more about safety and dosing of the study drug GS-4321 in healthy participants. The study will then learn about the safety and effectiveness of GS-4321 in participants with chronic hepatitis delta (CHD).\n\nThe primary objective of Phase 1 of this study is to evaluate the safety, tolerability and Pharmacokinetics (PK) of the escalating single doses of GS-4321 administered in healthy participants.\n\nThe primary objective of Phase 2 of this study is to evaluate the efficacy and safety of the multiple escalating doses of GS-4321 in participants with CHD.",[303],"Chronic Hepatitis Delta","2026-06-09",{"date":306,"type":307},"2026-06-11","ACTUAL",{"date":309,"type":307},"2025-07-31",{"date":311,"type":296},"2030-01",{"name":5,"class":6},19]