[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100525480":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":10,"locations":20,"responsibleParty":41,"collaborators":10,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":10,"enrollmentInfo":53,"targetDuration":10,"studyType":56,"phases":10,"briefSummary":57,"conditions":58,"keywords":10,"overallStatus":23,"whyStopped":10,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},{"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":10},"DRUG","Bulevirtide","dose of 2 mg\u002Fday subcutaneously",[9],[21],{"facility":22,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, Division of Gastroenterology and Hepatology, Milan, Italy.","RECRUITING","Milan","MI","20122","Italy","IT",{"type":30,"coordinates":31},"Point",[32,33],9.18951,45.46427,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":39,"phoneExt":10,"email":40},"Pietro Lampertico, MD","CONTACT","0255035432","pietro.lampertico@unimi.it",{"type":42,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100525480","effectiveness-and-safety-of-bulevirtide-blv-therapy-in-patients-with-chronic-hepatitis-delta-chd-in-italy-d-shield-100525480",false,"NCT06122285","Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy (D-SHIELD)","Effectiveness and Safety of Bulevirtide (BLV) Therapy in Patients With Chronic Hepatitis Delta (CHD) in Italy: a Multicenter Prospective Real Life Data Study","D-SHIELD","Inclusion Criteria:\n\n* 18 years of age or older\n* Chronic hepatitis delta\n* Compensated cirrhosis HDV related\n* Patients who will start therapy with BLV 2 mg\u002Fday from May 2023\n\nExclusion Criteria:\n\n* HDV-related decompensated cirrhosis (CPT ≥7)","ALL","18 Years",{"count":54,"type":55},100,"ESTIMATED","OBSERVATIONAL","Multicenter pharmacological observational prospective, no-profit, study.\n\nThis study was designed to get a \"real-life\" snapshot across several Italian Hepatology centers. All HDV patients are followed up according to EASL 2017 guidelines. This allows uniformity on the indication for antiviral treatment and management of that antiviral therapy. No off-label medications are used. All data are retrievable from the patient's medical record. In addition, clinical and biochemical data from patients at month 0, 1, 2, 4, 6 and 12 of treatment, and otherwise within the study period, will be collected longitudinally.\n\nThe primary objective of the study is to describe the virological response to BLV in all patients starting BLV therapy for CHD, defined as a \\>2 Log decline in HDV-RNA or undetectable HDV-RNA (using the Robogene 2.0 quantitative kit, LLQ \\\u003C6 IU\u002Fml) at month 12 of therapy.\n\nHDV patients who will start therapy with BLV 2 mg\u002Fday from May 2023, according to AIFA guidelines, will be consecutively enrolled.",[59],"Hepatitis D","2025-01-08",{"date":62,"type":63},"2025-01-10","ACTUAL",{"date":65,"type":63},"2023-05-01",{"date":67,"type":55},"2025-12-31",{"name":5,"class":6},1]