[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615257":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":248,"collaborators":22,"id":250,"slug":22,"hasResults":251,"nctId":252,"briefTitle":253,"officialTitle":253,"acronym":22,"eligibilityCriteria":254,"healthyVolunteers":251,"sex":255,"minAge":256,"maxAge":22,"enrollmentInfo":257,"targetDuration":22,"studyType":260,"phases":261,"briefSummary":263,"conditions":264,"keywords":267,"overallStatus":32,"whyStopped":22,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},{"fullName":5,"class":6},"Mirum Pharmaceuticals, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Livmarli","EXPERIMENTAL","ALGS: Primary cohort with a minimum of 45 previously untreated (treatment naïve). Supplemental cohort of participants who have previously received Livmarli.\n\nPFIC: Patients with Progressive Familial Intrahepatic Cholestasis treated with Livmarli. The study will enroll a minimum of 130 patients with PFIC",[13],"Drug: Livmarli Oral Product",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Livmarli Oral Product","Participants will be treated according to standard of care for the duration of the study and Schedule of Assessments.",[9],[21],"Maralixibat",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Clinical Trials Mirum","CONTACT","+16506674085","clinicaltrials@mirumpharma.com",[30,47,61,77,92,107,121,135,149,163,178,192,207,220,235],{"facility":31,"status":32,"city":33,"state":22,"zip":34,"country":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Cliniques Universitaires Saint Luc (UCLouvain)","RECRUITING","Brussels","1200","Belgium",{"type":37,"coordinates":38},"Point",[39,40],4.34878,50.85045,{"lat":40,"lon":39},[43],{"name":44,"role":26,"phone":45,"phoneExt":22,"email":46},"Stephenne Xavier","+32 2 764 13 77","xavier.stephenne@uclouvain.be",{"facility":48,"status":32,"city":49,"state":22,"zip":50,"country":35,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"University Hospital Gent (UZ Gent)","Ghent","9000",{"type":37,"coordinates":52},[53,54],3.71667,51.05,{"lat":54,"lon":53},[57],{"name":58,"role":26,"phone":59,"phoneExt":22,"email":60},"Ruth De Bruyne","+32 9 332 39 66","ruth.debruyne@ugent.be",{"facility":62,"status":32,"city":63,"state":64,"zip":65,"country":66,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Hospices Civils de Lyon - 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ISMETT","Palermo","Sicily","90127",{"type":37,"coordinates":184},[185,186],13.3636,38.1166,{"lat":186,"lon":185},[189],{"name":190,"role":26,"phone":22,"phoneExt":22,"email":191},"Giusy Ranucci","granucci@ismett.edu",{"facility":193,"status":32,"city":194,"state":22,"zip":195,"country":196,"cosmosGeoPoint":197,"geoPoint":201,"contacts":202},"University Medical Center Groningen (UMCG)","Groningen","9713GZ","Netherlands",{"type":37,"coordinates":198},[199,200],6.56667,53.21917,{"lat":200,"lon":199},[203],{"name":204,"role":26,"phone":205,"phoneExt":22,"email":206},"Henkjan Verkade","+31 50 3614147","h.j.verkade@umcg.nl",{"facility":208,"status":151,"city":209,"state":22,"zip":210,"country":211,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"Unidade Local de Saude de Coimbra Paediatric Department Avenida Afonso Romăo","Coimbra","3000-602","Portugal",{"type":37,"coordinates":213},[214,215],-8.41996,40.20686,{"lat":215,"lon":214},[218],{"name":219,"role":26,"phone":22,"phoneExt":22,"email":22},"Isabel Goncalves Costa",{"facility":221,"status":32,"city":222,"state":223,"zip":224,"country":225,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"Hospital Universitairo Vall D'Hebron","Barcelona","Catalonia","08035","Spain",{"type":37,"coordinates":227},[228,229],2.15899,41.38879,{"lat":229,"lon":228},[232],{"name":233,"role":26,"phone":22,"phoneExt":22,"email":234},"Jesus Quintero","jesus.quintero@vallhebron.cat",{"facility":236,"status":32,"city":237,"state":22,"zip":238,"country":225,"cosmosGeoPoint":239,"geoPoint":243,"contacts":244},"Hospital Universitario La Paz","Madrid","28046",{"type":37,"coordinates":240},[241,242],-3.70256,40.4165,{"lat":242,"lon":241},[245],{"name":246,"role":26,"phone":22,"phoneExt":22,"email":247},"Esteban Frauca Remacha","esteban.frauca@salud.madrid.org",{"type":249,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100615257",false,"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","ALL","2 Months",{"count":258,"type":259},230,"ESTIMATED","INTERVENTIONAL",[262],"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.",[265,266],"Alagille Syndrome","Progressive Familial Intrahepatic Cholestasis",[268,269,265,9,21,270,271,272,273,274],"ALGS","Liver Diseases","Cholestasis","Pruritus","Itching","IBAT inhibitor","PFIC","2026-06-18",{"date":277,"type":278},"2026-06-23","ACTUAL",{"date":280,"type":278},"2025-09-25",{"date":282,"type":259},"2030-12-22",{"name":5,"class":6},15]