[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"chronic-hepatitis-d\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:chronic-hepatitis-d":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100627915","phase-2-study-to-evaluate-switching-to-brelovitug-for-the-treatment-of-chd-in-participants-receiving-bulevirtide-100627915",false,"NCT07454837","Study to Evaluate Switching to Brelovitug for the Treatment of CHD in Participants Receiving Bulevirtide","A Phase 2b\u002F3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Male or female, ≥18 years of age at Screening.\n3. Taking or willing to take TDF, TAF, or ETV at baseline, and willing to remain on stable treatment for the duration of the study.\n4. Currently taking bulevirtide treatment for CHD for ≥6 months at the time of Screening.\n5. HDV RNA ≥100 IU\u002FmL at Screening.\n\nExclusion Criteria:\n\n1. Evidence of decompensated liver disease (e.g., CTP Class B or C, history of hepatic encephalopathy, clinically significant ascites, or variceal bleeding).\n2. Known history of immune-complex disease.\n3. Active or clinically significant co-infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).\n4. Evidence of other significant liver diseases (e.g., autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis).\n5. History of hepatocellular carcinoma (HCC) or evidence of HCC on screening imaging.","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE2","PHASE3","This is a Phase 2b\u002F3, randomized, open-label, multicenter trial evaluating the efficacy and safety of switching from bulevirtide to brelovitug for the treatment of chronic hepatitis Delta infection (CHD).",[27],"Chronic Hepatitis D","RECRUITING","2026-06-25",{"date":31,"type":32},"2026-06-29","ACTUAL",{"date":34,"type":32},"2026-02-26",{"date":36,"type":20},"2029-03-30",{"name":38,"class":39},"Mirum Pharmaceuticals, Inc.","INDUSTRY",35,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":4,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":58,"leadSponsor":60,"locationsCount":63},"100520014","study-to-evaluate-efficacy-safety-and-biomarkers-of-bulevirtide-treatment-in-chronic-hepatitis-d-patients-100520014","NCT06051045","Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Chronic Hepatitis D Patients","Observational Study to Evaluate Efficacy, Safety and Biomarkers of Bulevirtide Treatment in Patients With Chronic Hepatitis D","SEE-D","Inclusion Criteria:\n\n1. Age \\> 18 years\n2. Diagnosis of chronic HBV\u002FHDV co-infection.\n3. Have compensated liver disease (presence of portal hypertension without ongoing hepatic decompensation as ascites, variceal bleeding and hepatic encephalopathy allowed).\n4. Have indication for treatment of BLV, or already treated with BLV.\n5. For female\\* participants:\n\n   1. Postmenopausal for at least one year, or\n   2. Surgically sterile (total hysterectomy or bilateral oophorectomy, bilateral tubal ligation, staples, or another type of sterilization), or\n   3. Abstinence from heterosexual intercourse throughout the treatment period, or\n   4. Willingness to use highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive) throughout the treatment period and for 6 months after last dose of the drugs in the study.\n6. Male participants must agree to use a highly effective contraception (double barrier method or barrier contraception in combination with hormonal or intrauterine contraceptive used by female partners) throughout the treatment period and for 6 months after last dose of the drugs in the study.\n7. Participants who are willing to give written informed consent\n\nExclusion Criteria:\n\n1. Any contra-indications to treatment with BLV, including any intolerance or hypersensitivity to the active ingredient or other components of BLV.\n2. Pregnant or breast-feeding women.\n3. Patients with predictable difficulties of follow-up according to the investigator.\n4. Any other condition that, in the opinion of Investigator, precludes the patient from taking part in this study.",{"count":50,"type":20},400,"OBSERVATIONAL","The aim is to assess the efficacy and specific safety in an observational study of patients with Chronic hepatitis D (CHD) with prospective follow-up, with antiviral treatment of 2 mg Bulevirtide (BLV) +\u002F- PEG-IFNα-2a and +\u002F- NA given as part of the patient's routine medical care. Also, explorative endpoints of biomarkers in peripheral blood, saliva, fecal sample and\u002For intrahepatic markers\u002Fsignatures, and quality of life outcomes will be assessed.",[27],"2023-09-27",{"date":56,"type":32},"2023-09-29",{"date":54,"type":32},{"date":59,"type":20},"2033-03",{"name":61,"class":62},"Karolinska University Hospital","OTHER",1]