[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550445":3},{"organization":4,"outcomesModule":7,"designInfo":75,"detailedDescription":16,"studyPopulation":78,"armGroups":16,"interventions":16,"overallOfficials":79,"centralContacts":83,"locations":89,"responsibleParty":717,"collaborators":16,"id":719,"slug":720,"hasResults":721,"nctId":722,"briefTitle":723,"officialTitle":724,"acronym":725,"eligibilityCriteria":726,"healthyVolunteers":721,"sex":727,"minAge":16,"maxAge":16,"enrollmentInfo":728,"targetDuration":16,"studyType":731,"phases":16,"briefSummary":732,"conditions":733,"keywords":16,"overallStatus":92,"whyStopped":16,"lastUpdateSubmitDate":735,"lastUpdatePostDateStruct":736,"startDateStruct":739,"completionDateStruct":741,"leadSponsor":743,"locationsCount":744},{"fullName":5,"class":6},"Ipsen","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":16},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of participants with response to treatment","Defined as alkaline phosphatase (ALP) \\\u003C1.67 x upper limit of normal (ULN) and total bilirubin (TB) ≤ULN and ALP decrease ≥15% from baseline.","At month 6",[14,18,21,23,25,27,29,31,33,35,38,41,44,47,50,53,57,60,63,66,69,72],{"measure":15,"description":16,"timeFrame":17},"Percentage of participants with normalization of ALP levels",null,"Up to 60 months following enrollment, based on routine physician follow-up visit",{"measure":10,"description":19,"timeFrame":20},"Defined as ALP\\\u003C1.67 x ULN and TB≤ULN and ALP decrease ≥15% from baseline.","Up to 60 months following enrollment, based on routine physician follow-up visits",{"measure":22,"description":16,"timeFrame":17},"Change from baseline in liver function parameters: Serum levels of alanine aminotransferase (ALT)",{"measure":24,"description":16,"timeFrame":17},"Change from baseline in liver function parameters: Serum levels of Aspartate aminotransferase (AST)",{"measure":26,"description":16,"timeFrame":17},"Change from baseline in liver function parameters: Serum levels of Gamma-glutamyl transferase (GGT)",{"measure":28,"description":16,"timeFrame":17},"Change from baseline in liver function parameters: Serum levels of TB",{"measure":30,"description":16,"timeFrame":17},"Change from baseline in liver function parameters: Conjugated (direct) bilirubin",{"measure":32,"description":16,"timeFrame":17},"Change from baseline in liver function parameters: Serum levels of creatinine",{"measure":34,"description":16,"timeFrame":17},"Change from baseline in liver function parameters: Serum levels of albumin",{"measure":36,"description":37,"timeFrame":17},"Change from baseline in pruritus based on PBC Itch score","The PBC Itch score is a simple, self-administered Patient Reported Outcome (PRO) questionnaire that measures itch intensity. It uses 7-day recall periods and asks participants to rate the intensity of their worst itch over the past 7-day period on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).",{"measure":39,"description":40,"timeFrame":17},"Change from baseline in fatigue based on functional assessment of chronic illness therapy-fatigue (FACIT-Fatigue) scale","The FACIT-Fatigue is a 13-item measure that assesses self-reported fatigue and its impact upon daily activities and function. It is a subset of the longer (47-item) Functional Assessment of Cancer Therapy - Anemia (FACT-An), which includes the 27-item FACT-G and a 20-item subscale addressing additional concerns associated with the anemia of cancer and its treatment. This 20-item subscale, referred to as the anemia subscale, is comprised of 13-items that assess fatigue and its impact (the FACIT-Fatigue) and, 7 additional symptoms associated with anemia (e.g. shortness of breath, headache). participants rate their symptoms over the preceding seven days on a verbal response scale, the options range from 'not at all' \u002F 'a little bit' \u002F 'somewhat quite a bit' \u002F very much'.",{"measure":42,"description":43,"timeFrame":17},"Change from baseline in sleep based on Pittsburgh sleep quality index (PSQI)","The PSQI was designed to evaluate overall sleep quality in the psychiatric disorders associated with sleep disturbances. Each of the questionnaire's 19-self-reported items belongs to one of seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Five additional questions rated by the respondent's roommate or bed partner are included for clinical purposes and are not scored.",{"measure":45,"description":46,"timeFrame":17},"Change from baseline in Quality Of Life (QoL) based on PBC-40 questionnaire","The PBC-40 is a validated, PBC-specific, health-related Quality Of Life (QoL) questionnaire with 40 questions that assesses symptoms across six domains: fatigue, emotional and social, cognitive function, general symptoms and itch. Participants respond on a verbal response scale, depending on the section options range from 'never' \u002F 'not at all' \u002F 'strongly disagree' to 'always' \u002F 'very much'\u002F 'strongly agree'. Five items (3\u002F3 in the itch domain and 2\u002F10 in the social domain) also include a 'does not apply' option. A score for each domain is provided (but a total score is not calculated), with each verbal response scale correlating to a score of 1-5 per item (0-5 on items with a 'does not apply' option) with 5 being the most affected.",{"measure":48,"description":49,"timeFrame":17},"Change from baseline in QoL based on 5-Dimensional Itch scale (5-D Itch, also known as 5-D pruritus scale)","The 5-D Itch scale assesses symptoms in terms of five domains: degree, duration, direction, disability and distribution. It is a 1 to 5 scale, with 5 being the most affected.",{"measure":51,"description":52,"timeFrame":17},"Change from baseline in liver stiffness","Measured by transient elastography (FibroScan®) and enhanced liver fibrosis (ELF) test",{"measure":54,"description":55,"timeFrame":56},"Event free survival","Event free survival from first intake of commercialized elafibranor treatment as prescribed by physician to the first occurrence of any of the following clinical outcome events: (1) death, (2) liver transplant, and (3) liver decompensation.","From baseline to up to 60 months",{"measure":58,"description":59,"timeFrame":56},"Percentage of participants experiencing Adverse Events (AEs), Adverse Events of Special Interests (AESIs) and special situations (SS).","An Adverse event (AE) is any untoward medical occurrence, temporally associated with the use of study intervention, whether or not related to the study intervention. AESIs are AEs that may not be serious but are of special importance to a particular drug or class of drugs.",{"measure":61,"description":62,"timeFrame":17},"Participant's satisfaction on treatment","Measured by treatment satisfaction questionnaire for medication (TSQM). The TSQM (version 1.4) has 14 questions divided into 4 subscales: effectiveness (items 1 to 3), side effects (items 4 to 8), convenience (items 9 to 11), and global satisfaction (items 12 to 14).",{"measure":64,"description":65,"timeFrame":17},"Participant's adherence to treatment","Adherence to the treatment will be measured based on the participant report of missed doses every month.",{"measure":67,"description":68,"timeFrame":17},"Percentage of participants with clinically significant changes in laboratory parameters","Percentage of participants with clinically significant change in laboratory parameters (blood chemistry, hematology and coagulation) will be reported. The clinical significance will be graded by the investigator.",{"measure":70,"description":71,"timeFrame":17},"Percentage of participants with clinically significant changes in physical examination","Clinically significant changes in physical examination will be reported. The clinical significance will be graded by the investigator.",{"measure":73,"description":74,"timeFrame":17},"Percentage of participants developing clinically significant changes in vital signs","Clinically significant changes in vital signs will be reported. The clinical significance will be graded by the investigator.",{"allocation":16,"interventionModel":16,"interventionModelDescription":16,"primaryPurpose":16,"observationalModel":76,"timePerspective":77,"maskingInfo":16},"COHORT","PROSPECTIVE","Participants with PBC for whom the treating physician has decided to start treatment with elafibranor 80 mg\u002Fday, as recommended in the approved indication.",[80],{"name":81,"affiliation":5,"role":82},"Ipsen Medical Director","STUDY_DIRECTOR",[84],{"name":85,"role":86,"phone":87,"phoneExt":16,"email":88},"Ipsen Clinical Study Enquiries","CONTACT","See e mail","clinical.trials@ipsen.com",[90,104,114,123,133,143,153,163,173,183,193,203,213,223,232,242,251,261,271,277,287,297,306,316,324,332,344,352,360,368,376,386,391,399,407,415,423,431,439,449,457,465,473,481,491,499,507,515,523,531,536,545,553,561,566,571,581,589,594,603,611,619,629,634,639,644,654,662,670,678,686,693,701,709],{"facility":91,"status":92,"city":93,"state":94,"zip":95,"country":96,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":103,"contacts":16},"Southern California Research Center","RECRUITING","Coronado","California","92118","United States","US",{"type":99,"coordinates":100},"Point",[101,102],-117.18309,32.68589,{"lat":102,"lon":101},{"facility":105,"status":106,"city":107,"state":94,"zip":108,"country":96,"countryCode":97,"cosmosGeoPoint":109,"geoPoint":113,"contacts":16},"Cedars-Sinai Medical Center","NOT_YET_RECRUITING","Los Angeles","90048",{"type":99,"coordinates":110},[111,112],-118.24368,34.05223,{"lat":112,"lon":111},{"facility":115,"status":92,"city":116,"state":94,"zip":117,"country":96,"countryCode":97,"cosmosGeoPoint":118,"geoPoint":122,"contacts":16},"University of California Davis Medical Center","Sacramento","95817",{"type":99,"coordinates":119},[120,121],-121.4944,38.58157,{"lat":121,"lon":120},{"facility":124,"status":92,"city":125,"state":126,"zip":127,"country":96,"countryCode":97,"cosmosGeoPoint":128,"geoPoint":132,"contacts":16},"South Denver Gastroenterology,P.C.","Englewood","Colorado","80113",{"type":99,"coordinates":129},[130,131],-104.98776,39.64777,{"lat":131,"lon":130},{"facility":134,"status":92,"city":135,"state":136,"zip":137,"country":96,"countryCode":97,"cosmosGeoPoint":138,"geoPoint":142,"contacts":16},"Yale University School of Medicine","New Haven","Connecticut","06510",{"type":99,"coordinates":139},[140,141],-72.92816,41.30815,{"lat":141,"lon":140},{"facility":144,"status":92,"city":145,"state":146,"zip":147,"country":96,"countryCode":97,"cosmosGeoPoint":148,"geoPoint":152,"contacts":16},"Schiff Center for Liver Diseases - University of Miami","Miami","Florida","33136",{"type":99,"coordinates":149},[150,151],-80.19366,25.77427,{"lat":151,"lon":150},{"facility":154,"status":92,"city":155,"state":156,"zip":157,"country":96,"countryCode":97,"cosmosGeoPoint":158,"geoPoint":162,"contacts":16},"Beth Israel Deaconess Medical Center, Liver Research Center","Boston","Massachusetts","02215",{"type":99,"coordinates":159},[160,161],-71.05977,42.35843,{"lat":161,"lon":160},{"facility":164,"status":92,"city":165,"state":166,"zip":167,"country":96,"countryCode":97,"cosmosGeoPoint":168,"geoPoint":172,"contacts":16},"Virtua Center for Liver Disease - Cherry Hill","Cherry Hill","New Jersey","08034",{"type":99,"coordinates":169},[170,171],-75.03073,39.93484,{"lat":171,"lon":170},{"facility":174,"status":92,"city":175,"state":176,"zip":177,"country":96,"countryCode":97,"cosmosGeoPoint":178,"geoPoint":182,"contacts":16},"Northwell Health Inc, Center for Liver Disease and Transplantation","Manhasset","New York","11030",{"type":99,"coordinates":179},[180,181],-73.69957,40.79788,{"lat":181,"lon":180},{"facility":184,"status":92,"city":185,"state":186,"zip":187,"country":96,"countryCode":97,"cosmosGeoPoint":188,"geoPoint":192,"contacts":16},"UNC Hospitals, The University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27599",{"type":99,"coordinates":189},[190,191],-79.05584,35.9132,{"lat":191,"lon":190},{"facility":194,"status":92,"city":195,"state":196,"zip":197,"country":96,"countryCode":97,"cosmosGeoPoint":198,"geoPoint":202,"contacts":16},"Cleveland Clinic Foundation","Cleveland","Ohio","44195",{"type":99,"coordinates":199},[200,201],-81.69541,41.4995,{"lat":201,"lon":200},{"facility":204,"status":92,"city":205,"state":206,"zip":207,"country":96,"countryCode":97,"cosmosGeoPoint":208,"geoPoint":212,"contacts":16},"Medical University of South Carolina (MUSC)","Charleston","South Carolina","29425",{"type":99,"coordinates":209},[210,211],-79.93275,32.77632,{"lat":211,"lon":210},{"facility":214,"status":92,"city":215,"state":216,"zip":217,"country":96,"countryCode":97,"cosmosGeoPoint":218,"geoPoint":222,"contacts":16},"Liver Center of Texas","Dallas","Texas","75234",{"type":99,"coordinates":219},[220,221],-96.80667,32.78306,{"lat":221,"lon":220},{"facility":224,"status":92,"city":225,"state":216,"zip":226,"country":96,"countryCode":97,"cosmosGeoPoint":227,"geoPoint":231,"contacts":16},"Baylor College of Medicine - Advanced Liver Therapies","Houston","77030",{"type":99,"coordinates":228},[229,230],-95.36327,29.76328,{"lat":230,"lon":229},{"facility":233,"status":234,"city":235,"state":216,"zip":236,"country":96,"countryCode":97,"cosmosGeoPoint":237,"geoPoint":241,"contacts":16},"Gastro health & Nutrition","WITHDRAWN","Katy","77494",{"type":99,"coordinates":238},[239,240],-95.8244,29.78579,{"lat":240,"lon":239},{"facility":243,"status":92,"city":244,"state":216,"zip":245,"country":96,"countryCode":97,"cosmosGeoPoint":246,"geoPoint":250,"contacts":16},"Texas Digestive Specialists","McAllen","78504",{"type":99,"coordinates":247},[248,249],-98.23001,26.20341,{"lat":249,"lon":248},{"facility":252,"status":92,"city":253,"state":254,"zip":255,"country":96,"countryCode":97,"cosmosGeoPoint":256,"geoPoint":260,"contacts":16},"Intermountain Medical Center","Murray","Utah","84107",{"type":99,"coordinates":257},[258,259],-111.88799,40.66689,{"lat":259,"lon":258},{"facility":262,"status":92,"city":263,"state":264,"zip":265,"country":96,"countryCode":97,"cosmosGeoPoint":266,"geoPoint":270,"contacts":16},"Bon Secours Richmond Community Hospital LLC. d\u002Fb\u002Fa Bon Secours Liver Institute of Richmond","Richmond","Virginia","23226",{"type":99,"coordinates":267},[268,269],-77.46026,37.55376,{"lat":269,"lon":268},{"facility":272,"status":92,"city":263,"state":264,"zip":273,"country":96,"countryCode":97,"cosmosGeoPoint":274,"geoPoint":276,"contacts":16},"Virginia Commonwealth University Medical Center - West Hospital","23298",{"type":99,"coordinates":275},[268,269],{"lat":269,"lon":268},{"facility":278,"status":92,"city":279,"state":280,"zip":281,"country":96,"countryCode":97,"cosmosGeoPoint":282,"geoPoint":286,"contacts":16},"Velocity Clinical Research","Seattle","Washington","98105",{"type":99,"coordinates":283},[284,285],-122.33207,47.60621,{"lat":285,"lon":284},{"facility":288,"status":106,"city":289,"state":16,"zip":16,"country":290,"countryCode":291,"cosmosGeoPoint":292,"geoPoint":296,"contacts":16},"Royal Prince Alfred Hospital","Camperdown","Australia","AU",{"type":99,"coordinates":293},[294,295],151.17642,-33.88965,{"lat":295,"lon":294},{"facility":298,"status":92,"city":299,"state":16,"zip":300,"country":290,"countryCode":291,"cosmosGeoPoint":301,"geoPoint":305,"contacts":16},"St Vincent's Hospital","Fitzroy","3065",{"type":99,"coordinates":302},[303,304],144.97833,-37.79839,{"lat":304,"lon":303},{"facility":307,"status":92,"city":308,"state":16,"zip":16,"country":309,"countryCode":310,"cosmosGeoPoint":311,"geoPoint":315,"contacts":16},"Medizinische Universitaetsklinik Graz","Graz","Austria","AT",{"type":99,"coordinates":312},[313,314],15.44197,47.06733,{"lat":314,"lon":313},{"facility":317,"status":92,"city":318,"state":16,"zip":16,"country":309,"countryCode":310,"cosmosGeoPoint":319,"geoPoint":323,"contacts":16},"Medical University Innsbruck","Innsbruck",{"type":99,"coordinates":320},[321,322],11.39454,47.26266,{"lat":322,"lon":321},{"facility":325,"status":92,"city":326,"state":16,"zip":16,"country":309,"countryCode":310,"cosmosGeoPoint":327,"geoPoint":331,"contacts":16},"Ordensklinikum Linz GmbH Barmherzige Schwestern","Linz",{"type":99,"coordinates":328},[329,330],14.28611,48.30639,{"lat":330,"lon":329},{"facility":333,"status":92,"city":334,"state":335,"zip":336,"country":337,"countryCode":338,"cosmosGeoPoint":339,"geoPoint":343,"contacts":16},"Centre de Recherche du Centre Hospitalier de l'Universite de Montreal (CRCHUM)","Montreal","Quebec","H2X 0A9","Canada","CA",{"type":99,"coordinates":340},[341,342],-73.58781,45.50884,{"lat":342,"lon":341},{"facility":345,"status":92,"city":346,"state":16,"zip":16,"country":337,"countryCode":338,"cosmosGeoPoint":347,"geoPoint":351,"contacts":16},"University of Calgary","Calgary",{"type":99,"coordinates":348},[349,350],-114.08529,51.05011,{"lat":350,"lon":349},{"facility":353,"status":92,"city":354,"state":16,"zip":16,"country":337,"countryCode":338,"cosmosGeoPoint":355,"geoPoint":359,"contacts":16},"London Health Sciences Centre (LHSC) - University Hospital","London",{"type":99,"coordinates":356},[357,358],-81.23304,42.98339,{"lat":358,"lon":357},{"facility":361,"status":92,"city":362,"state":16,"zip":16,"country":337,"countryCode":338,"cosmosGeoPoint":363,"geoPoint":367,"contacts":16},"The Ottawa Hospital - General Campus","Ottawa",{"type":99,"coordinates":364},[365,366],-75.69812,45.41117,{"lat":366,"lon":365},{"facility":369,"status":92,"city":370,"state":16,"zip":16,"country":337,"countryCode":338,"cosmosGeoPoint":371,"geoPoint":375,"contacts":16},"(G.I.R.I) GI Research Institute Foundation","Vancouver",{"type":99,"coordinates":372},[373,374],-123.11934,49.24966,{"lat":374,"lon":373},{"facility":377,"status":92,"city":378,"state":16,"zip":16,"country":379,"countryCode":380,"cosmosGeoPoint":381,"geoPoint":385,"contacts":16},"Charite Universitatsmedizin Berlin","Berlin","Germany","DE",{"type":99,"coordinates":382},[383,384],13.41053,52.52437,{"lat":384,"lon":383},{"facility":387,"status":92,"city":378,"state":16,"zip":16,"country":379,"countryCode":380,"cosmosGeoPoint":388,"geoPoint":390,"contacts":16},"DRK Kliniken Berlin Mitte",{"type":99,"coordinates":389},[383,384],{"lat":384,"lon":383},{"facility":392,"status":106,"city":393,"state":16,"zip":16,"country":379,"countryCode":380,"cosmosGeoPoint":394,"geoPoint":398,"contacts":16},"Klinikum der Johann Wolfgang Goethe-Universitaet","Frankfurt",{"type":99,"coordinates":395},[396,397],10.53333,49.68333,{"lat":397,"lon":396},{"facility":400,"status":92,"city":401,"state":16,"zip":16,"country":379,"countryCode":380,"cosmosGeoPoint":402,"geoPoint":406,"contacts":16},"Studiengesellschaft BSF","Halle",{"type":99,"coordinates":403},[404,405],11.97947,51.48158,{"lat":405,"lon":404},{"facility":408,"status":92,"city":409,"state":16,"zip":16,"country":379,"countryCode":380,"cosmosGeoPoint":410,"geoPoint":414,"contacts":16},"Gastroenterologsiche Studiengesellschaft Herne","Herne",{"type":99,"coordinates":411},[412,413],7.22572,51.5388,{"lat":413,"lon":412},{"facility":416,"status":92,"city":417,"state":16,"zip":16,"country":379,"countryCode":380,"cosmosGeoPoint":418,"geoPoint":422,"contacts":16},"Universitaet des Saarlandes","Homburg",{"type":99,"coordinates":419},[420,421],7.33867,49.32637,{"lat":421,"lon":420},{"facility":424,"status":92,"city":425,"state":16,"zip":16,"country":379,"countryCode":380,"cosmosGeoPoint":426,"geoPoint":430,"contacts":16},"Universitaetsklinikum Leipzig","Leipzig",{"type":99,"coordinates":427},[428,429],12.37129,51.33962,{"lat":429,"lon":428},{"facility":432,"status":234,"city":433,"state":16,"zip":16,"country":379,"countryCode":380,"cosmosGeoPoint":434,"geoPoint":438,"contacts":16},"Hospital of the Merciful Brothers Trier","Trier",{"type":99,"coordinates":435},[436,437],6.63935,49.75565,{"lat":437,"lon":436},{"facility":440,"status":92,"city":441,"state":16,"zip":16,"country":442,"countryCode":443,"cosmosGeoPoint":444,"geoPoint":448,"contacts":16},"General Hospital of Athens Laiko","Athens","Greece","GR",{"type":99,"coordinates":445},[446,447],23.72784,37.98376,{"lat":447,"lon":446},{"facility":450,"status":92,"city":451,"state":16,"zip":16,"country":442,"countryCode":443,"cosmosGeoPoint":452,"geoPoint":456,"contacts":16},"University Hospital of Heraklion","Heraklion",{"type":99,"coordinates":453},[454,455],25.14341,35.32787,{"lat":455,"lon":454},{"facility":458,"status":92,"city":459,"state":16,"zip":16,"country":442,"countryCode":443,"cosmosGeoPoint":460,"geoPoint":464,"contacts":16},"University General Hospital of Larissa","Larissa",{"type":99,"coordinates":461},[462,463],22.42112,39.62847,{"lat":463,"lon":462},{"facility":466,"status":92,"city":467,"state":16,"zip":16,"country":442,"countryCode":443,"cosmosGeoPoint":468,"geoPoint":472,"contacts":16},"University General Hospital of Patras","Pátrai",{"type":99,"coordinates":469},[470,471],21.73508,38.2462,{"lat":471,"lon":470},{"facility":474,"status":92,"city":475,"state":16,"zip":16,"country":442,"countryCode":443,"cosmosGeoPoint":476,"geoPoint":480,"contacts":16},"Ippokratio General Hospital of Thessaloniki","Thessaloniki",{"type":99,"coordinates":477},[478,479],22.93493,40.64072,{"lat":479,"lon":478},{"facility":482,"status":92,"city":483,"state":16,"zip":16,"country":484,"countryCode":485,"cosmosGeoPoint":486,"geoPoint":490,"contacts":16},"ASST-Ospedale Papa Giovanni XXIII","Bergamo","Italy","IT",{"type":99,"coordinates":487},[488,489],9.66721,45.69601,{"lat":489,"lon":488},{"facility":492,"status":92,"city":493,"state":16,"zip":16,"country":484,"countryCode":485,"cosmosGeoPoint":494,"geoPoint":498,"contacts":16},"Ospedale Garibaldi Nesima","Catania",{"type":99,"coordinates":495},[496,497],15.07041,37.49223,{"lat":497,"lon":496},{"facility":500,"status":92,"city":501,"state":16,"zip":16,"country":484,"countryCode":485,"cosmosGeoPoint":502,"geoPoint":506,"contacts":16},"Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)","Florence",{"type":99,"coordinates":503},[504,505],11.24626,43.77925,{"lat":505,"lon":504},{"facility":508,"status":92,"city":509,"state":16,"zip":16,"country":484,"countryCode":485,"cosmosGeoPoint":510,"geoPoint":514,"contacts":16},"ASST Grande Ospedale Metropolitano Niguarda","Milan",{"type":99,"coordinates":511},[512,513],12.59836,42.78235,{"lat":513,"lon":512},{"facility":516,"status":92,"city":517,"state":16,"zip":16,"country":484,"countryCode":485,"cosmosGeoPoint":518,"geoPoint":522,"contacts":16},"Ospedale Maggiore Della Carita","Novara",{"type":99,"coordinates":519},[520,521],8.62118,45.44694,{"lat":521,"lon":520},{"facility":524,"status":92,"city":525,"state":16,"zip":16,"country":484,"countryCode":485,"cosmosGeoPoint":526,"geoPoint":530,"contacts":16},"A. 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Freeman Hospital","Newcastle",{"type":99,"coordinates":697},[698,699],-5.88979,54.21804,{"lat":699,"lon":698},{"facility":702,"status":106,"city":703,"state":16,"zip":16,"country":647,"countryCode":648,"cosmosGeoPoint":704,"geoPoint":708,"contacts":16},"Queen's Medical Centre - Nottingham University Hospitals NHS Trust","Nottingham",{"type":99,"coordinates":705},[706,707],-1.15047,52.9536,{"lat":707,"lon":706},{"facility":710,"status":92,"city":711,"state":16,"zip":16,"country":647,"countryCode":648,"cosmosGeoPoint":712,"geoPoint":716,"contacts":16},"John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust","Oxford",{"type":99,"coordinates":713},[714,715],-1.25596,51.75222,{"lat":715,"lon":714},{"type":718,"investigatorFullName":16,"investigatorTitle":16,"investigatorAffiliation":16,"oldNameTitle":16,"oldOrganization":16},"SPONSOR","100550445","a-study-observing-everyday-effectiveness-and-safety-of-the-drug-elafibranor-in-participants-with-primary-biliary-cholangitis-who-are-receiving-ongoing-treatment-100550445",false,"NCT06447168","A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment","Prospective Non-interventional, Phase IV Multicentre Study to Assess the Effectiveness, Safety and Tolerability of Elafibranor 80 mg\u002FDay in Participants With Primary Biliary Cholangitis Receiving Treatment in a Real-world Setting.","ELFINITY","Inclusion Criteria:\n\n* Participant has provided written informed consent and agrees to comply with the study protocol.\n* Participant with PBC diagnosis.\n* Participant for whom the treating physician has decided to start or participants who are currently receiving treatment with commercialized elafibranor.\n* If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected.\n\nExclusion Criteria:\n\n* Participant is currently participating or, plans to participate in an investigational drug study or medical device study containing active substance.\n* Participant with known hypersensitivity to the product or to any of its excipients.\n* Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.","ALL",{"count":729,"type":730},424,"ESTIMATED","OBSERVATIONAL","This study will collect information from participants with Primary Biliary Cholangitis (PBC) as they use the drug elafibranor in real world setting.\n\nPBC is a progressive rare liver disease in which tubes in the liver called bile ducts are damaged.\n\nThe liver damage in PBC may lead to scarring (cirrhosis). PBC may also be associated with multiple symptoms including pruritus (itching) and fatigue. Many patients with PBC may require liver transplant or may die if the disease progresses and a liver transplant is not done.\n\nIn this study the main aim is to observe the effectiveness, safety and tolerability of elafibranor in participants with PBC who are receiving treatment in real world setting. The total study duration for each participants will be 60 months (approximately 5 years).",[734],"Primary Biliary Cholangitis","2026-07-31",{"date":737,"type":738},"2026-08-03","ACTUAL",{"date":740,"type":738},"2024-10-14",{"date":742,"type":730},"2032-07-15",{"name":5,"class":6},74]