[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617033":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":26,"responsibleParty":59,"collaborators":62,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":10,"eligibilityCriteria":79,"healthyVolunteers":76,"sex":80,"minAge":81,"maxAge":10,"enrollmentInfo":82,"targetDuration":10,"studyType":85,"phases":10,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":93,"whyStopped":10,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"University of Rome Tor Vergata","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"HDV-BLV",null,"patients with HDV infection who initiated BLV from January 2023 to February 2025 for whom retrospective data and samples are available. Follow-up and sample collection will be extended for this population over the period of the study grant.\n\nTo be eligible for inclusion in both the retrospective and prospective part of the study, participants have to be ≥18 years of age, have signed an informed consent and satisfy the following additional criteria:\n\nA diagnosis of chronic HDV infection with or without compensated cirrhosis Having started BLV monotherapy 2mg\u002Fday according to the criteria reported in the recent clinical practice guidelines on HDV infection promoted by EASL \\[EASL CPG 2024\\] Be under effective treatment with nucleoside analogues with HBV-DNA \\\u003C20 IU\u002Fml at the time of starting BLV",[13],{"name":14,"affiliation":15,"role":16},"PIETRO LAMPERTICO, PROFESSOR","UNIVERSITA' DI MILANO","PRINCIPAL_INVESTIGATOR",[18,23],{"name":19,"role":20,"phone":21,"phoneExt":10,"email":22},"VALENTINA SVICHER, PROFESSOR","CONTACT","+39 333 238 1462","valentina.svicher@uniroma2.it",{"name":24,"role":20,"phone":10,"phoneExt":10,"email":25},"ROMINA SALPINI, RESEARCHER","romina.salpini@uniroma2.it",[27,44],{"facility":28,"status":10,"city":29,"state":30,"zip":31,"country":30,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Heinrich Heine University","Düsseldorf","Germany","40225","DE",{"type":34,"coordinates":35},"Point",[36,37],6.77927,51.22319,{"lat":37,"lon":36},[40],{"name":41,"role":20,"phone":42,"phoneExt":10,"email":43},"BJORN ERIK O JENSEN","+49 211 81 18942","Jensen@med.uni-duesseldorf.de",{"facility":45,"status":10,"city":46,"state":47,"zip":48,"country":47,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"Università di Milano","Milan","Italy","20122","IT",{"type":34,"coordinates":51},[52,53],12.59836,42.78235,{"lat":53,"lon":52},[56],{"name":14,"role":20,"phone":57,"phoneExt":10,"email":58},"+390255035432","pietro.lampertico@unimi.it",{"type":16,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Valentina Svicher","Professor",[63,65,67,69,71],{"name":64,"class":6},"Euresist Network GEIE",{"name":66,"class":6},"Informapro Srl",{"name":68,"class":6},"Royal Free and University College Medical School",{"name":70,"class":6},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico",{"name":72,"class":73},"EUROPEAN LIVER PATIENTS ASSOCIATION","UNKNOWN","100617033","10119473--viromarkers-hdv-biomarkers-study-100617033",false,"NCT07313358","10119473 -VIROMARKERS HDV Biomarkers Study","Inclusion Criteria:\n\n* Be \\> 18 years of age\n* Sign an informed consent\n* Have a diagnosis of HDV infection with or without compensated cirrhosis\n* Having started BLV monotherapy 2mg\u002Fday according to the criteria reported in the recent clinical practice guidelines on HDV infection promoted by EASL (EASL CPG 2023)\n* Be under effective treatment with nucleoside analogues with HBV-DNA \\\u003C20 IU\u002Fml at the time of starting BLV\n\nExclusion Criteria:\n\n* Decompensated liver disease\n* BLV combined with pegIFN\n* Past treatment with BLV","ALL","18 Years",{"count":83,"type":84},220,"ESTIMATED","OBSERVATIONAL","This is an observational study, in which clinical data, samples, and any other procedures possibly already performed on participants, were performed within the scope of clinical practice or within the scope of otherwise authorized projects, and that therefore there are no procedures performed specifically for this study, which instead uses data collected previously or prospectively during an extended follow-up, but in any case within the scope of current clinical practice. Most participants have been enrolled and followed up at the project partners' clinical sites over 2023-2025. Their follow-up and sample collection will continue over the duration of the project. At the time of enrollment, demographics, medical history, medications and treatments prescribed were recorded and will be used in this study if the participant consent to be included also in VIROMARKERS. HDV genotypes\u002Fsubgenotypes will be determined ex-novo on existing baseline stored samples.\n\nThe harmonization of HDV-RNA assays by utilizing standardized and validated flowcharts still represents a relevant diagnostic unmet clinical need for the appropriate monitoring of patients with CHD receiving BLV treatment. Furthermore, information on long-term virological response and factors predictive of virological outcome is scarce.\n\nSpecific primary objectives to characterise the response to bulevirtide in CHD include:\n\n* To estimate the percentage of participants who will achieve virological response (defined as a decline in serum HDV RNA of \\>2 log or to undetectable HDV-RNA) and the proportion achieving undetectable HDV-RNA at week 48, 96 and 144 weeks of BLV treatment.\n* To estimate the percentage of participants who will achieve biochemical response and combined response (defined as achievement of virological response and ALT normalization) at week 48, 96 and 144 weeks of BLV treatment.\n* To evaluate whether HDV-RNA levels at baseline or their kinetics during the first 12 weeks of BLV treatment can predict the achievement of undetectable serum HDV-RNA during BLV treatment.",[88],"HDV Infection",[90,91,92],"HDV infection","bulevirtide","biomarkers","NOT_YET_RECRUITING","2026-01-19",{"date":96,"type":97},"2026-01-22","ACTUAL",{"date":99,"type":84},"2026-02-20",{"date":101,"type":84},"2026-10-30",{"name":5,"class":6},2]