[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07096193":3,"trial-entities:NCT07096193":321,"trial-summary:NCT07096193":327},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":26,"interventions":29,"primary_outcomes":44,"secondary_outcomes":68,"sex":103,"minimum_age":104,"maximum_age":105,"healthy_volunteers":106,"eligibility_criteria":107,"std_ages":122,"locations":125,"central_contacts":306,"overall_officials":312,"references":316,"see_also_links":317},"NCT07096193","GS-US-567-6968","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","RECRUITING","2030-01","2026-08","2026-08-27","2025-07-31","Gilead Sciences","INDUSTRY",false,"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.",null,[19],"Chronic Hepatitis Delta",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},200,"ESTIMATED",[30,36,41],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","GS-4321","Administered subcutaneous (SC) or intravenously IV",[35],"Phase 1: GS-4321",{"type":31,"name":37,"description":38,"armGroupLabels":39},"GS-4321 Placebo","Administered SC",[40],"Phase 1: Placebo",{"type":31,"name":32,"description":38,"armGroupLabels":42},[43],"Phase 2: GS-4321",[45,48,50,52,56,59,62,64],{"measure":46,"timeFrame":47},"Phase 1 and 2: Percentage of Participants With Treatment-emergent Adverse Events","Phase 1: First dose up to 44 weeks; Phase 2: First dose up to 96 Weeks plus 48 weeks of posttreatment follow-up",{"measure":49,"timeFrame":47},"Phase 1 and 2: Percentage of Participants With Treatment-emergent Serious Adverse Events",{"measure":51,"timeFrame":47},"Phase 1 and 2: Percentage of Participants Experiencing Treatment-emergent Clinical Laboratory Abnormalities",{"measure":53,"description":54,"timeFrame":55},"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":57,"description":58,"timeFrame":55},"Phase 1: Serum PK Parameter: Cmax","Cmax is defined as the maximum observed concentration of drug.",{"measure":60,"description":61,"timeFrame":55},"Phase 1: Serum PK Parameter: Tmax","Tmax is defined as the time (observed time point) of Cmax.",{"measure":63,"timeFrame":55},"Phase 1: Serum PK Parameter: t1\u002F2",{"measure":65,"description":66,"timeFrame":67},"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",[69,72,75,77,79,81,84,87,90,93,96,98,101],{"measure":70,"description":71,"timeFrame":55},"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":73,"timeFrame":74},"Phase 2: Serum PK Parameters AUC of GS-4321","Up to 96 weeks",{"measure":76,"timeFrame":67},"Phase 2: Serum PK Parameters Cmax of GS-4321",{"measure":78,"timeFrame":67},"Phase 2: Serum PK Parameters Tmax of GS-4321",{"measure":80,"timeFrame":67},"Phase 2: Serum PK Parameters Ctrough of GS-4321",{"measure":82,"timeFrame":83},"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":85,"timeFrame":86},"Phase 2: Change From Baseline in HDV RNA","Baseline, Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96",{"measure":88,"timeFrame":89},"Phase 2: Proportion of Participants With Undetectable HDV RNA","Weeks 4, 8, 12, 16, 20, 24, 36, 48, 60, 72, 84, and 96",{"measure":91,"timeFrame":92},"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":94,"timeFrame":95},"Phase 2: Change From Baseline in Liver Stiffness by Elastography","Weeks 24, 48, and 96",{"measure":97,"timeFrame":89},"Phase 2: Proportion of Participants with normal ALT",{"measure":99,"description":71,"timeFrame":100},"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":102,"timeFrame":100},"Phase 2: Characterize if Emergent Variants are Associated With Reduced Susceptibility to GS-4321 in Vitro and Virologic Failure in Participants With CHD","ALL","18 Years","69 Years",true,{"inclusion":108,"exclusion":116,"raw_text":121},[109,110,109,111,112,113,114,115],"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.","Have a body mass index (BMI) of ≤ 30.0 kg\u002Fm2 at screening and at admission.","Chronic hepatitis delta (CHD) for ≥ 6 months prior to screening, documented by prior medical history.","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.","Non-cirrhotic or compensated cirrhosis.","Hepatitis delta virus ribonucleic acid (HDV RNA ) \\> 500 IU\u002FmL at screening.","Alanine aminotransferase (ALT) level \\> 1 × Upper limit of normal (ULN), but \\\u003C 10 × ULN at screening.",[117,118,117,118,119,120],"Positive serum or urine pregnancy test.","Participants with plans to breastfeed during the study period.","Current or previous clinically decompensated liver disease, including coagulopathy, hepatic encephalopathy, and esophageal varices hemorrhage due to HDV or HBV.","Child-Turcotte-Pugh (CTP)-B or -C or a CTP score of ≥ 7.","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.",[123,124],"ADULT","OLDER_ADULT",[126,135,142,150,158,165,173,181,189,194,201,209,213,217,224,232,239,246,250,257,264,268,275,283,287,291,295,302],{"facility":127,"status":8,"city":128,"state":129,"zip":130,"country":131,"geoPoint":132},"Investigative Site","Anaheim","California","92801","United States",{"lat":133,"lon":134},33.83529,-117.9145,{"facility":136,"status":8,"city":137,"state":129,"zip":138,"country":131,"geoPoint":139},"University of California, San Diego - Altman Clinical and Translational Research Institute","La Jolla","92093",{"lat":140,"lon":141},32.84727,-117.2742,{"facility":143,"status":8,"city":144,"state":145,"zip":146,"country":131,"geoPoint":147},"University of Louisville, Clinical Trials Unit","Louisville","Kentucky","40202",{"lat":148,"lon":149},38.25424,-85.75941,{"facility":151,"status":8,"city":152,"state":153,"zip":154,"country":131,"geoPoint":155},"University of Maryland, Institute of Human Virology, Clinical Research Unit","Baltimore","Maryland","21201",{"lat":156,"lon":157},39.29038,-76.61219,{"facility":159,"status":8,"city":160,"state":160,"zip":161,"country":131,"geoPoint":162},"The New York-Presbyterian Hospital","New York","10021",{"lat":163,"lon":164},40.71427,-74.00597,{"facility":166,"status":8,"city":167,"zip":168,"country":169,"geoPoint":170},"University Multi-profile Hospital for Active Treatment \"SofiaMed\" 00D","Sofia","1797","Bulgaria",{"lat":171,"lon":172},42.69751,23.32415,{"facility":174,"status":8,"city":175,"zip":176,"country":177,"geoPoint":178},"Medizinische Hochschule Hannover, Address: Klinik für Gastroenterologie, Hepatologie, Infektiologie und Endokrinologie","Hanover","30625","Germany",{"lat":179,"lon":180},52.37052,9.73322,{"facility":182,"status":8,"city":183,"zip":184,"country":185,"geoPoint":186},"Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, SC Gastroenterologia ed Epatologia","Milan","882","Italy",{"lat":187,"lon":188},42.78235,12.59836,{"facility":190,"status":8,"city":191,"zip":192,"country":193},"IMSP Spitalul Clinic de Boli Infectioase \"Toma Ciorba\"","Chinsinau","2004","Moldova",{"facility":195,"status":8,"city":196,"zip":197,"country":193,"geoPoint":198},"PMSI Clinical Republican Hospital \"Timofei Mosneaga\"","Chisinau","MD-2025",{"lat":199,"lon":200},47.00902,28.85938,{"facility":202,"status":8,"city":203,"zip":204,"country":205,"geoPoint":206},"Institutul National De Boli Infectioase Prof. Dr. Matei Bals","Bucharest","021105","Romania",{"lat":207,"lon":208},44.43225,26.10626,{"facility":210,"status":8,"city":203,"zip":211,"country":205,"geoPoint":212},"Fundatia Dr. Victor Babes","030303",{"lat":207,"lon":208},{"facility":214,"status":8,"city":203,"zip":215,"country":205,"geoPoint":216},"Infectious Diseases Institutul National De Boli Infectioase Prof. Matei Bals","21105",{"lat":207,"lon":208},{"facility":218,"status":8,"city":219,"zip":220,"country":205,"geoPoint":221},"Gastromedica S.R.L.","Iași","700506",{"lat":222,"lon":223},47.16667,27.6,{"facility":225,"status":8,"city":226,"zip":227,"country":228,"geoPoint":229},"Korea University Ansan Hospital","Ansan-si","425-707","South Korea",{"lat":230,"lon":231},37.32361,126.82194,{"facility":233,"status":8,"city":234,"zip":235,"country":228,"geoPoint":236},"The Catholic University of Korea Bucheon St. Mary's Hospital","Bucheon-si","14647",{"lat":237,"lon":238},37.49889,126.78306,{"facility":240,"status":8,"city":241,"zip":242,"country":228,"geoPoint":243},"The Catholic University of Korea, Seoul St. Mary's Hospital","Seoul","06591",{"lat":244,"lon":245},37.566,126.9784,{"facility":247,"status":8,"city":241,"zip":248,"country":228,"geoPoint":249},"Samsung Medical Center","135-710",{"lat":244,"lon":245},{"facility":251,"status":8,"city":252,"country":253,"geoPoint":254},"Ditmanson Medical Foundation Chia-Yi Christian Hospital","Chiayi City","Taiwan",{"lat":255,"lon":256},23.47917,120.44889,{"facility":258,"status":8,"city":259,"zip":260,"country":253,"geoPoint":261},"Kaohsiung Medical University Chung-Ho Memorial Hospital","Kaohsiung City","807",{"lat":262,"lon":263},22.61626,120.31333,{"facility":265,"status":8,"city":259,"zip":266,"country":253,"geoPoint":267},"Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital","83301",{"lat":262,"lon":263},{"facility":269,"status":8,"city":270,"zip":271,"country":253,"geoPoint":272},"National Taiwan University Hospital","Taipei","100",{"lat":273,"lon":274},25.05306,121.52639,{"facility":276,"status":8,"city":277,"zip":278,"country":279,"geoPoint":280},"Hacettepe University Faculty of Medicine Hospital Hacettepe Neighborhood","Ankara","06430","Turkey (Türkiye)",{"lat":281,"lon":282},39.91987,32.85427,{"facility":284,"status":8,"city":277,"zip":285,"country":279,"geoPoint":286},"Ankara Bilkent City Hospital Oncology Hospital Universiteler Neighborhood","06800",{"lat":281,"lon":282},{"facility":288,"status":8,"city":277,"zip":289,"country":279,"geoPoint":290},"Ankara Bilkent City Hospital Universiteler Neighborhood, 1604th Street No: 9,","6800",{"lat":281,"lon":282},{"facility":292,"status":8,"city":293,"zip":294,"country":279},"Dicle University Faculty of Medicine","Diyarbakrir","21280",{"facility":296,"status":8,"city":297,"zip":298,"country":279,"geoPoint":299},"Istabul University-Cerrahpasa Faculty of Medicine Hospital","Istanbul","34000",{"lat":300,"lon":301},41.01384,28.94966,{"facility":303,"status":8,"city":297,"zip":304,"country":279,"geoPoint":305},"Koc University Medical Faculty Hospital","34010",{"lat":300,"lon":301},[307],{"name":308,"role":309,"phone":310,"email":311},"Gilead Clinical Study Information Center","CONTACT","1-833-445-3230 (GILEAD-0)","GileadClinicalTrials@gilead.com",[313],{"name":314,"affiliation":13,"role":315},"Gilead Study Director","STUDY_DIRECTOR",[],[318],{"label":319,"url":320},"Gilead Clinical Trials Website","https:\u002F\u002Fwww.gileadclinicaltrials.com\u002Fstudy?nctid=NCT07096193",{"nct_id":4,"conditions":322,"biomarkers":325},[323,324],"Chronic hepatitis E","Healthy Volunteers",[326],"HDV RNA",{"nct_id":4,"found":106,"summary":328,"prompt_version":338},{"design":329,"status":330,"heading":331,"summary":332,"follow_up":333,"word_count":334,"commitments":335,"compensation":336,"drugs_mentioned":337},"This interventional study will involve about 200 participants, including healthy volunteers and those with chronic hepatitis delta. It will test different doses of GS-4321.","completed","Study of GS-4321 for Chronic Hepatitis Delta","This study is testing a drug called GS-4321 for chronic hepatitis delta (CHD). First, it will look at the safety and how the body handles GS-4321 in healthy volunteers. Then, it will study the safety and how well GS-4321 works in people with CHD. The drug will be given either under the skin (subcutaneous) or into a vein (intravenously). Researchers will be watching for any side effects, serious side effects, and abnormal lab results to understand the safety of GS-4321. You may be able to join if you are between 18 and 69 years old and meet other health requirements, including a body mass index (BMI) of 30.0 kg\u002Fm2 or less. The study aims to enroll about 200 participants.","Participants with chronic hepatitis delta will have a post-treatment follow-up period of 48 weeks after their last dose.",119,"Participants will receive GS-4321 or a placebo. Safety will be monitored for up to 44 weeks in healthy participants and up to 96 weeks in those with chronic hepatitis delta.","Not stated in the trial record.",[32],"v2"]