[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Mirum Pharmaceuticals, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":177},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,75,104,127,154],{"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":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100615257","phase-4-long-term-low-intervention-safety-and-clinical-outcomes-clinical-study-of-livmarli-in-patients-with-alagille-syndrome-or-progressive-familial-intrahepatic-cholestasis-in-the-european-union-leap-eu-100615257","NCT07290257","Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union (LEAP-EU)","Inclusion Criteria:\n\n* Understand and execute an Informed consent and assent (as applicable)\n* For participants with ALGS ≥2 months of age at Day 1\n* For participants with PFIC, ≥3 months of age at Day 1\n* A clinically and\u002For genetically confirmed ALGS diagnosis with pruritus secondary to chronic cholestasis, or a clinically and\u002For genetically confirmed PFIC diagnosis\n* For the ALGS primary cohort: Initiation of Livmarli at the time of study entry\n* For the ALGS supplemental cohort, : Actively using Livmarli prior to study entry\n* For participants with PFIC: Prescribed Livmarli at the time of study entry or prior to study entry\n\nExclusion Criteria:\n\n* History of Liver Transplant\n* Any Livmarli contraindications (as per SmPC)\n* Any condition or abnormality that, in the opinion of the investigator, may interfere with the participation in or completion of the study\n* Received an investigational drug within 30 days before the first dose of Livmarli (Participation in previous maralixibat studies or expanded-access programs is acceptable.)\n* Received another IBAT inhibitor within 7 days before the first dose of Livmarli\n* Baseline data before start of treatment of Livmarli are unavailable (\\\u003C2 values before treatment) for key safety (LFTs, FSV laboratory results) and key efficacy (sBA, pruritus) parameter","2 Months",{"count":49,"type":20},230,[51],"PHASE4","In patients with Alagille syndrome (ALGS), the key objectives are to evaluate the tolerability, long-term safety (including possible liver toxicity) and long-term efficacy of Livmarli treatment.\n\nIn patients with Progressive Familial Intrahepatic Cholestasis (PFIC), the key objectives are to evaluate tolerability, long-term safety (including possible liver toxicity and potential impact of chronic exposure to propylene glycol (PG)), long-term efficacy, and growth and development.",[54,55],"Alagille Syndrome","Progressive Familial Intrahepatic Cholestasis",[57,58,54,59,60,61,62,63,64,65],"ALGS","Liver Diseases","Livmarli","Maralixibat","Cholestasis","Pruritus","Itching","IBAT inhibitor","PFIC","2026-06-18",{"date":68,"type":32},"2026-06-23",{"date":70,"type":32},"2025-09-25",{"date":72,"type":20},"2030-12-22",{"name":38,"class":39},15,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":74},"100609046","phase-2-study-of-mrm-3379-in-male-participants-with-fragile-x-syndrome-bloom-100609046","NCT07209462","Study of MRM-3379 in Male Participants With Fragile X Syndrome (BLOOM)","Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of MRM-3379 in Male Participants With Fragile X Syndrome","Inclusion Criteria:\n\n* Willing and able to provide signed informed consent\u002Fassent. Where local regulations permit inclusion of participants deemed unable to provide informed consent, a legally authorized representative must provide informed consent on the participant's behalf, and the participant must provide assent if applicable.\n* Male, 13-45 years of age (inclusive)\n* Weight ≥30 kg and BMI between 18 and 36 kg\u002Fm2 (inclusive) at the screening visit\n* Diagnosis of FXS with a molecular genetic ≥200 CGG repetitions .\n* Able to perform the PVT and ORRT of the NIH-TCB\n* Have a consistent caregiver(s) who is willing and able to be present regularly and reliably with the participant\n* Able to swallow tablets or capsules\n\nExclusion Criteria:\n\nHistory of or current medical condition other than FXS and related issues that would place the participant at higher risk from study participation","MALE","13 Years","45 Years",{"count":86,"type":20},60,[23],"This study is a multicenter, double-blind, randomized, placebo-controlled study to assess the safety and tolerability of 3 doses of MRM-3379 in male participants with Fragile X Syndrome ages 16 to 45 (inclusive). In addition, a parallel cohort of participants ages 13 to \\\u003C16 will receive open-label MRM-3379. All participants will participate for 12 weeks of treatment. The study is also intended as a proof-of-concept investigation to evaluate whether MRM-3379 can improve FXS symptoms",[90],"Fragile X Syndrome",[90,92,93,94,95],"FXS","FMR","Phosphodiesterase 4","PDE4","2026-06-11",{"date":98,"type":32},"2026-06-15",{"date":100,"type":32},"2025-11-22",{"date":102,"type":20},"2027-10",{"name":38,"class":39},{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":120,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100608388","phase-3-a-trial-evaluating-brelovitug-bjt-778-vs-bulevirtide-for-the-treatment-of-chronic-hepatitis-delta-infection-azure-2-100608388","NCT07200908","A Trial Evaluating Brelovitug (BJT-778) vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)","A Global, Randomized, Open-label, Multicenter Phase 3 Trial Evaluating BJT-778 vs Bulevirtide for the Treatment of Chronic Hepatitis Delta Infection (AZURE-2)","Key Inclusion Criteria:\n\n1. Willing and able to provide written informed consent\n2. Chronic HDV infection\n3. HDV RNA \\>500 IU\u002FmL at Screening\n4. ALT \\>ULN at Screening\n5. Willing to take or already taking HBV neucleos(t)ide therapy.\n\nKey Exclusion Criteria:\n\n1. Pregnant or nursing females\n2. Unwilling to comply with contraception requirements during the study\n3. Difficulty with blood collection and\u002For poor venous access for the purposes of phlebotomy\n4. Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).\n5. Solid organ or bone marrow transplantation\n6. Presence of other liver disease(s) (non-HBV\u002FHDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.\n\nNote - Other protocol-defined Inclusion\u002FExclusion criteria apply.","99 Years",{"count":113,"type":20},172,[24],"This is a Phase 3, global, randomized, open-label, multicenter, trial evaluating brelovitug (BJT-778) vs bulevirtide for the treatment of chronic hepatitis delta infection (CHD). The main goal of this study is to test the effectiveness of brelovitug compared to bulevirtide as a long-term treatment in patients with chronic HDV infection.",[117],"Chronic Hepatitis D Infection",[119],"Hepatitis Delta virus, HDV, Hepatitis D infection; Hepatitis D virus",{"date":98,"type":32},{"date":122,"type":32},"2025-08-27",{"date":124,"type":20},"2029-09-30",{"name":38,"class":39},48,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":137,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},"100443111","phase-2-a-study-to-evaluate-efficacy-and-safety-of-an-investigational-drug-named-volixibat-in-patients-with-itching-caused-by-primary-biliary-cholangitis-100443111","NCT05050136","A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis","A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients With Primary Biliary Cholangitis","VANTAGE","Inclusion Criteria:\n\n* Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study\n* Male or female, age ≥18 years at the screening visit\n* Confirmed diagnosis of PBC in line with the AASLD guidelines\n* UDCA, anti-pruritic medication and PPAR agonist use will be allowed if meeting additional criteria\n* Qualified pruritus associated with PBC as assessed by Adult ItchRO\n\nExclusion Criteria:\n\n* Pruritus associated with an etiology other than PBC\n* Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events\n* Current symptomatic cholelithiasis or inflammatory gallbladder disease\n* History of small bowel surgery\u002Fresection impacting the terminal ileum that may disrupt the enterohepatic circulation.\n* Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded\n* History of Liver transplantation",{"count":136,"type":20},260,[23],"The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.",[140,141],"Primary Biliary Cholangitis","PBC",[62,141,63,143,140,144],"Cholangitis","Hepatobiliary disorders","2026-05-12",{"date":147,"type":32},"2026-05-14",{"date":149,"type":32},"2021-09-22",{"date":151,"type":20},"2027-07",{"name":38,"class":39},130,{"id":155,"slug":156,"hasResults":11,"nctId":157,"briefTitle":158,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":161,"targetDuration":163,"studyType":164,"phases":4,"briefSummary":165,"conditions":166,"keywords":167,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":176},"100530987","long-term-safety-and-clinical-outcomes-of-livmarli-in-patients-in-the-united-states-leap-us-100530987","NCT06193928","Long-Term SafEty and Clinical Outcomes of LivmArli in Patients in the United States (LEAP-US)","LEAP","Inclusion Criteria:\n\n* A clinically and\u002For genetically confirmed ALGS diagnosis or PFIC diagnosis\n* Participant prescribed Livmarli\n\nExclusion Criteria:\n\n* Refusal to provide informed consent\u002Fassent (if required by the local IRB)\n* Previously or currently on Livmarli through participation in a clinical study or expanded access program\n* Participants who have previously received an SBD or LT\n* Any condition or abnormalities that, in the opinion of the investigator, may interfere with the participant participating in or completing the study\n* Participants who have received an investigational drug within 30 days of the first dose of Livmarli",{"count":162,"type":20},70,"5 Years","OBSERVATIONAL","The objective of this 5-year, prospective, observational cohort study is to evaluate the long-term safety and clinical outcomes of patients with Alagille syndrome (ALGS) or Progressive familial intrahepatic cholestasis (PFIC) treated with Livmarli.",[54,55],[57,58,65,59,54,55],"2025-05-21",{"date":170,"type":32},"2025-05-25",{"date":172,"type":32},"2023-09-21",{"date":174,"type":20},"2030-09-20",{"name":38,"class":39},8,""]