[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100402031":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":79,"collaborators":81,"id":85,"slug":86,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":10,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":10,"studyType":98,"phases":10,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"PBC patients offered bezafibrate treatment",null,"All patients started on bezafibrate treatment are offered inclusion in the study.\n\nFirst visit is before start of treatment. Afterwards patients will be seen at 4 weeks, 6 months, 1 year, 2 years and 3 years after inclusion.\n\nAt all visits blood samples will be taken and liver stiffness will be measured using FibroScan. Further, they will be asked about pruritus.",[13,14,15],"Other: Blood sampling","Device: Fibroscan","Other: Question",[17,20,25],{"type":6,"name":18,"description":18,"armGroupLabels":19,"otherNames":10},"Blood sampling",[9],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"DEVICE","Fibroscan","Measurement of liver stiffness",[9],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":10},"Question","Question about pruritus",[9],[30],{"name":31,"affiliation":32,"role":33},"Henning Grønbæk, Prof, MD","Aarhus University Hospital","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":10,"email":38},"CONTACT","+45 21679281","henngroe@rm.dk",{"name":40,"role":36,"phone":41,"phoneExt":10,"email":42},"Lars Bossen, MD","+45 22800676","larsbossen@clin.au.dk",[44,63],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Department of Hepatology and Gastroenterology, Aarhus University Hospital, Denmark","RECRUITING","Aarhus N","Central Jutland","8200","Denmark","DK",{"type":53,"coordinates":54},"Point",[55,56],10.17317,56.20367,{"lat":56,"lon":55},[59,62],{"name":60,"role":36,"phone":61,"phoneExt":10,"email":42},"Lars Bossen, PhD-student","+45 2280 0676",{"name":31,"role":33,"phone":10,"phoneExt":10,"email":10},{"facility":64,"status":46,"city":65,"state":10,"zip":66,"country":50,"countryCode":51,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Department of Medicine, Gastrounit Medical division","Hvidovre","2650",{"type":53,"coordinates":68},[69,70],12.47708,55.64297,{"lat":70,"lon":69},[73,76],{"name":74,"role":36,"phone":10,"phoneExt":10,"email":75},"Henriette Ytting, MD, PhD","henriette.lambert@regionh.dk",{"name":77,"role":78,"phone":10,"phoneExt":10,"email":10},"Line Molzen, MD","SUB_INVESTIGATOR",{"type":80,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[82,83],{"name":32,"class":6},{"name":84,"class":6},"Hvidovre University Hospital","100402031","bezafibrate-in-patients-with-primary-biliary-cholangitis-pbc-100402031",false,"NCT04514965","Bezafibrate in Patients With Primary Biliary Cholangitis (PBC)","Measuring Macrophage Activation Markers and Influence on Bile Acid Composition in Patients With Primary Biliary Cholangitis After Treatment With Bezafibrate","Inclusion Criteria:\n\n* PBC patient offered bezafibrate treatment\n\nExclusion Criteria:\n\n* patient age under 18\n* life expectancy less than 6 months\n* known cancer\n* planned liver transplantation within 6 months\n* other liver disease (viral, autoimmune, alcohol, NAFLD\u002FNASH)","ALL","18 Years","99 Years",{"count":96,"type":97},100,"ESTIMATED","OBSERVATIONAL","Up to 40% of patients with PBC have an inadequate response to standard treatment with UDCA, hence bezafibrate, a PPAR-agonist is being introduced as add-on therapy in these patients. sCD163, fibrosis markers and bile acid composition are of special interest in PBC. In this study, the investigators will investigate how treatment with bezafibrate influence levels of macrophage activation markers and fibrosis markers as well as bile acid composition in patients offered bezafibrate as add-on therapy to UDCA.",[101],"Primary Biliary Cirrhosis",[103,104,105,106],"Bezafibrate","Macrophage activation markers","Fibrosis markers","Bile acid composition","2022-08-11",{"date":109,"type":110},"2022-08-12","ACTUAL",{"date":112,"type":110},"2020-10-01",{"date":114,"type":97},"2026-09",{"name":5,"class":6},2]