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Hannover","Hanover","30625","Germany","DE",{"type":57,"coordinates":109},[110,111],9.73322,52.37052,{"lat":111,"lon":110},{"facility":114,"status":50,"city":115,"state":30,"zip":116,"country":117,"countryCode":118,"cosmosGeoPoint":119,"geoPoint":123,"contacts":30},"Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, SC Gastroenterologia ed Epatologia","Milan","882","Italy","IT",{"type":57,"coordinates":120},[121,122],12.59836,42.78235,{"lat":122,"lon":121},{"facility":125,"status":50,"city":126,"state":30,"zip":127,"country":128,"countryCode":129,"cosmosGeoPoint":30,"geoPoint":30,"contacts":30},"IMSP Spitalul Clinic de Boli Infectioase \"Toma 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Bals","Bucharest","021105","Romania","RO",{"type":57,"coordinates":150},[151,152],26.10626,44.43225,{"lat":152,"lon":151},{"facility":155,"status":50,"city":145,"state":30,"zip":156,"country":147,"countryCode":148,"cosmosGeoPoint":157,"geoPoint":159,"contacts":30},"Fundatia Dr. Victor Babes","030303",{"type":57,"coordinates":158},[151,152],{"lat":152,"lon":151},{"facility":161,"status":50,"city":145,"state":30,"zip":162,"country":147,"countryCode":148,"cosmosGeoPoint":163,"geoPoint":165,"contacts":30},"Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals","21105",{"type":57,"coordinates":164},[151,152],{"lat":152,"lon":151},{"facility":167,"status":50,"city":168,"state":30,"zip":169,"country":147,"countryCode":148,"cosmosGeoPoint":170,"geoPoint":174,"contacts":30},"Gastromedica S.R.L.","Iași","700506",{"type":57,"coordinates":171},[172,173],27.6,47.16667,{"lat":173,"lon":172},{"facility":176,"status":50,"city":177,"state":30,"zip":178,"country":179,"countryCode":30,"cosmosGeoPoint":180,"geoPoint":184,"contacts":30},"Korea University Ansan Hospital","Ansan-si","425-707","South Korea",{"type":57,"coordinates":181},[182,183],126.82194,37.32361,{"lat":183,"lon":182},{"facility":186,"status":50,"city":187,"state":30,"zip":188,"country":179,"countryCode":30,"cosmosGeoPoint":189,"geoPoint":193,"contacts":30},"The Catholic University of Korea Bucheon St. Mary's Hospital","Bucheon-si","14647",{"type":57,"coordinates":190},[191,192],126.78306,37.49889,{"lat":192,"lon":191},{"facility":195,"status":50,"city":196,"state":30,"zip":197,"country":179,"countryCode":30,"cosmosGeoPoint":198,"geoPoint":202,"contacts":30},"The Catholic University of Korea, Seoul St. Mary's Hospital","Seoul","06591",{"type":57,"coordinates":199},[200,201],126.9784,37.566,{"lat":201,"lon":200},{"facility":204,"status":50,"city":196,"state":30,"zip":205,"country":179,"countryCode":30,"cosmosGeoPoint":206,"geoPoint":208,"contacts":30},"Samsung Medical Center","135-710",{"type":57,"coordinates":207},[200,201],{"lat":201,"lon":200},{"facility":210,"status":50,"city":211,"state":30,"zip":30,"country":212,"countryCode":213,"cosmosGeoPoint":214,"geoPoint":218,"contacts":30},"Ditmanson Medical Foundation Chia-Yi Christian Hospital","Chiayi City","Taiwan","TW",{"type":57,"coordinates":215},[216,217],120.44889,23.47917,{"lat":217,"lon":216},{"facility":220,"status":50,"city":221,"state":30,"zip":222,"country":212,"countryCode":213,"cosmosGeoPoint":223,"geoPoint":227,"contacts":30},"Kaohsiung Medical University Chung-Ho Memorial Hospital","Kaohsiung City","807",{"type":57,"coordinates":224},[225,226],120.31333,22.61626,{"lat":226,"lon":225},{"facility":229,"status":50,"city":221,"state":30,"zip":230,"country":212,"countryCode":213,"cosmosGeoPoint":231,"geoPoint":233,"contacts":30},"Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital","83301",{"type":57,"coordinates":232},[225,226],{"lat":226,"lon":225},{"facility":235,"status":50,"city":236,"state":30,"zip":237,"country":212,"countryCode":213,"cosmosGeoPoint":238,"geoPoint":242,"contacts":30},"National Taiwan University Hospital","Taipei","100",{"type":57,"coordinates":239},[240,241],121.52639,25.05306,{"lat":241,"lon":240},{"type":244,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"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 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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":257,"type":258},200,"ESTIMATED","INTERVENTIONAL",[261,262],"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.",[265],"Chronic Hepatitis Delta","2026-07-29",{"date":268,"type":269},"2026-07-30","ACTUAL",{"date":271,"type":269},"2025-07-31",{"date":273,"type":258},"2030-01",{"name":5,"class":6},22]