[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100546662":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":10,"locations":22,"responsibleParty":42,"collaborators":10,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":10,"enrollmentInfo":54,"targetDuration":10,"studyType":57,"phases":10,"briefSummary":58,"conditions":59,"keywords":10,"overallStatus":25,"whyStopped":10,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},{"fullName":5,"class":6},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Hepatis Delta",null,"Bulevirtide (BLV) at a dose of 2 mg\u002Fday subcutaneously",[13],"Drug: Bulevirtide",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Bulevirtide","dose of 2 mg\u002Fday subcutaneously",[9],[21],"Hepcludex",[23],{"facility":24,"status":25,"city":26,"state":10,"zip":27,"country":28,"countryCode":29,"cosmosGeoPoint":30,"geoPoint":35,"contacts":36},"Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.","RECRUITING","Milan","20122","Italy","IT",{"type":31,"coordinates":32},"Point",[33,34],12.59836,42.78235,{"lat":34,"lon":33},[37],{"name":38,"role":39,"phone":40,"phoneExt":10,"email":41},"Pietro Lampertico, MD","CONTACT","0255035432","pietro.lampertico@unimi.it",{"type":43,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100546662","effectiveness-and-clinical-outcomes-of-long-term-bulevirtide-monotherapy-in-patients-with-hdv-related-compensated-cirrhosis-100546662",false,"NCT06397859","Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis","Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis (SAVE-D Study)","SAVE-D","Inclusion Criteria:\n\n* Age≥18 years\n* HDV-related compensated cirrhosis defined by positivity of HDV RNA for at least 6 months and clinical or laboratory or histological diagnosis of cirrhosis\n* Started treatment with BLV monotherapy between September 1st 2019 and 2025\n\nExclusion Criteria:\n\n* Chronic hepatitis without any evidence of cirrhosis\n* Decompensated cirrhosis\n* PegIFN alpha therapy","ALL","18 Years",{"count":55,"type":56},266,"ESTIMATED","OBSERVATIONAL","Retrospective and prospective, pharmacological, multicentre, non-profit observational study.\n\nConsecutive patients with HDV-related compensated cirrhosis starting Bulevirtide 2 mg\u002Fday from September 2019 to December 2025 will be enrolled in the study.\n\nAim of this study is to investigate virological and clinical effectiveness of Bulevirtide 2 mg\u002Fday in patients with HDV-related compensated cirrhosis in the real-life setting.\n\nPrimary endpoint of the study is the rate of virological response, defined as at least 2 Log decline or undetectable HDV RNA compared to baseline, at week 96 of treatment.",[60],"Hepatitis D","2024-06-14",{"date":63,"type":64},"2024-06-17","ACTUAL",{"date":66,"type":64},"2024-05-06",{"date":68,"type":56},"2026-08-31",{"name":5,"class":6},1]