[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625994":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":13,"locations":18,"responsibleParty":39,"collaborators":7,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":44,"sex":50,"minAge":51,"maxAge":7,"enrollmentInfo":52,"targetDuration":7,"studyType":55,"phases":7,"briefSummary":56,"conditions":57,"keywords":67,"overallStatus":21,"whyStopped":7,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",null,[9],{"name":10,"affiliation":11,"role":12},"Francesca Romana Ponziani","Fondazione Policlinico A. Gemelli IRCCS","PRINCIPAL_INVESTIGATOR",[14],{"name":10,"role":15,"phone":16,"phoneExt":7,"email":17},"CONTACT","+390630159336","francescaromana.ponziani@policlinicogemelli.it",[19],{"facility":20,"status":21,"city":22,"state":7,"zip":23,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Fondazione Policlinico Universitaro A. Gemelli IRCSS UOC CEMAD","RECRUITING","Roma","00168","Italy","IT",{"type":27,"coordinates":28},"Point",[29,30],11.10642,44.99364,{"lat":30,"lon":29},[33,35],{"name":10,"role":15,"phone":34,"phoneExt":7,"email":17},"3471227242",{"name":36,"role":15,"phone":37,"phoneExt":16,"email":38},"Elisabetta Creta","+393480778584","elisabetta.creta@policlinicogemelli.it",{"type":12,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":7,"oldOrganization":7},"Ponziani Francesca Romana","Medical Director","100625994","changes-in-bile-acids-and-microbiota-in-patients-with-hepatitis-d-treated-with-bulvertide-100625994",false,"NCT07429864","Changes in Bile Acids and Microbiota in Patients With Hepatitis D Treated With Bulvertide","Changes in Bile Acid Profile and Gut Microbiota in Patients Undergoing Treatment With Bulevirtide for Hepatitis Delta Virus Infection","Bio-Delta","Inclusion Criteria:\n\n* Patients with chronic HDV-related hepatitis or compensated liver cirrhosis (Child-Pugh class A)\n* Positive HDV RNA within the 24 weeks prior to enrollment\n* Ongoing antiviral therapy for HBV at the time of enrollment\n* First prescription of Bulevirtide 2 mg issued within 30 days prior to enrollment\n* Caucasian ethnicity\n* Age ≥18 years\n* Normocaloric omnivorous diet\n* No intake of antibiotics, probiotics, or prebiotics in the month prior to enrollment\n* Signed informed consent\n\nExclusion Criteria:\n\n* Decompensated liver cirrhosis (Child-Pugh Score B or C)\n* Patients without HBV-HDV-related infection\u002Fhepatitis\u002Fcirrhosis\n* Age ≤18 years\n* Pregnant or breastfeeding women\n* Concomitant diseases with short life expectancy (solid or hematologic neoplasms, heart failure NYHA III\u002FIV, COPD GOLD C-D)\n* Conditions (celiac disease, chronic inflammatory bowel diseases) or use of medications (antibiotics, probiotics, prebiotics) capable of altering gut microbiota composition","ALL","18 Years",{"count":53,"type":54},20,"ESTIMATED","OBSERVATIONAL","HDV is an RNA virus that infects only in the presence of HBV, affecting about 13% of HBsAg carriers. In Italy, prevalence ranges from 3.2% to 9.3%. It increases the risk of cirrhosis, fulminant hepatitis, and HCC, particularly in high-risk groups (HIV, HCV, drug users, dialysis patients). Until 2020, pegIFN was the only therapy; since 2022, bulevirtide (BLV) has been available, blocking viral entry into hepatocytes and reducing HDV RNA and liver stiffness, with efficacy in 45-48% of patients, though the optimal treatment duration remains uncertain. The gut microbiota and bile acids also play a role in fibrosis and cirrhosis progression: dysbiosis, typical in cirrhotic patients, alters bile acid metabolism and increases intrahepatic toxicity.",[58,59,60,61,62,63,64,65,66],"HBV","HBV Coinfection","HCV","HIV Infections","Hepatocellular Carcinoma","Cirrhosis, Liver","Fibrosis, Liver","Bile Acid Malabsorption","Microbial Colonization",[68,69,70],"gut microbiota","Bile Acids","dysbiosis","2026-02-17",{"date":73,"type":74},"2026-02-24","ACTUAL",{"date":76,"type":74},"2025-09-24",{"date":78,"type":54},"2027-10",{"name":5,"class":6},1]