[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05050136":3,"trial-entities:NCT05050136":1010,"trial-summary:NCT05050136":1014},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":50,"secondary_outcomes":55,"sex":75,"minimum_age":76,"maximum_age":17,"healthy_volunteers":77,"eligibility_criteria":78,"std_ages":93,"locations":96,"central_contacts":1002,"overall_officials":1003,"references":1004,"see_also_links":1009},"NCT05050136","VLX-601","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","ACTIVE_NOT_RECRUITING","2028-12","2026-08","2026-08-25","2021-09-22","Mirum Pharmaceuticals, Inc.","INDUSTRY",true,"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.",null,[19,20],"Primary Biliary Cholangitis","PBC",[22,20,23,24,19,25],"Pruritus","Itching","Cholangitis","Hepatobiliary disorders","INTERVENTIONAL","TREATMENT",[29],"PHASE2",{"count":31,"type":32},333,"ACTUAL",[34,44],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":42},"DRUG","Volixibat","Oral capsules, administered twice daily. Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor.",[39,40,41],"Part 1 Arm 1: Volixibat 20mg","Part 1 Arm 2: Volixibat 80mg","Part 2 Arm 1: Volixibat Selected Dose 20mg",[43],"SHP626",{"type":35,"name":45,"description":46,"armGroupLabels":47},"Placebo","Capsules matched to study drug without the active pharmaceutical ingredient",[48,49],"Part 1 Arm 3: Placebo","Part 2 Arm 2: Placebo",[51],{"measure":52,"description":53,"timeFrame":54},"Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire","The Adult ItchRO is an 11-point NRS measurement of itch severity ranging from 0=no itch to 10=worst possible itch.","Baseline to week 28",[56,58,60,62,64,66,69,72],{"measure":57,"timeFrame":54},"Proportion of participants with itch response using the Adult ItchRO",{"measure":59,"timeFrame":54},"Incidence of adverse events",{"measure":61,"timeFrame":54},"Changes in alkaline phosphatase",{"measure":63,"timeFrame":54},"Changes in total bilirubin",{"measure":65,"timeFrame":54},"Changes in serum bile acid levels",{"measure":67,"description":68,"timeFrame":54},"Change in Primary Biliary Cholangitis Quality of Life Measure (PBC-40)","PBC-40 questionnaire is scored on a scale of 40 to 200, with higher scores indicating poorer quality of life",{"measure":70,"description":71,"timeFrame":54},"Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) fatigue questionnaire","The PROMIS® Fatigue questionnaire is a 5-point response scale. Respondents endorse each item using a 5-point response scale: Never, Rarely, Sometimes, Often, and Always.",{"measure":73,"description":74,"timeFrame":54},"Change in Patient-Reported Outcomes Measurement Information System (PROMIS®) sleep disturbance questionnaire","The PROMIS® Sleep Disturbance in an 8-item measure that assesses quality of sleep, sleep depth, and restoration associated with sleep. It is a 5-point response scale, the specific response options vary by items. The first 4 items use response options that range from Not at all to Very much. The next 3 items use response options that range from Never to Always. The final item assesses sleep quality ranging from Very poor to Very good.","ALL","18 Years",false,{"inclusion":79,"exclusion":85,"raw_text":92},[80,81,82,83,84],"Provide signed informed consent at the screening visit as well as comply with all study visits and requirements through the end of the study","Male or female, age ≥18 years at the screening visit","Confirmed diagnosis of PBC in line with the AASLD guidelines","UDCA, anti-pruritic medication and PPAR agonist use will be allowed if meeting additional criteria","Qualified pruritus associated with PBC as assessed by Adult ItchRO",[86,87,88,89,90,91],"Pruritus associated with an etiology other than PBC","Evidence or clinical suspicion of decompensated cirrhosis or a history of decompensation events","Current symptomatic cholelithiasis or inflammatory gallbladder disease","History of small bowel surgery\u002Fresection impacting the terminal ileum that may disrupt the enterohepatic circulation.","Evidence, history, or suspicion of other liver diseases; PBC patients with AIH are not excluded","History of Liver transplantation","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",[94,95],"ADULT","OLDER_ADULT",[97,106,113,117,124,132,140,148,155,162,169,176,183,190,197,204,212,220,227,235,243,250,258,262,270,278,286,294,302,310,318,326,334,341,349,356,363,370,373,380,388,396,403,410,418,427,435,439,446,454,461,468,477,485,493,501,508,512,519,528,532,540,547,554,562,569,573,582,590,598,606,613,617,621,629,636,643,650,657,664,672,678,685,692,699,706,713,720,727,735,742,746,753,757,764,771,778,785,792,799,806,810,817,824,831,838,845,851,860,864,868,875,882,890,897,903,911,915,919,926,933,940,948,955,964,972,979,985,989,996],{"facility":98,"city":99,"state":100,"zip":101,"country":102,"geoPoint":103},"Southern California Research Center","Coronado","California","92218","United States",{"lat":104,"lon":105},32.68589,-117.18309,{"facility":107,"city":108,"state":100,"zip":109,"country":102,"geoPoint":110},"Cedars Sinai Medical Center","Los 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Hepatology Research at CTRB","Gainesville","32610",{"lat":153,"lon":154},29.65163,-82.32483,{"facility":156,"city":157,"state":143,"zip":158,"country":102,"geoPoint":159},"UF Health Gastroenterology- Emerson","Jacksonville","32209",{"lat":160,"lon":161},30.33218,-81.65565,{"facility":163,"city":164,"state":143,"zip":165,"country":102,"geoPoint":166},"IHS Health","Kissimmee","34741",{"lat":167,"lon":168},28.30468,-81.41667,{"facility":170,"city":171,"state":143,"zip":172,"country":102,"geoPoint":173},"Schiff Center for Liver Diseases","Miami","33136",{"lat":174,"lon":175},25.77427,-80.19366,{"facility":177,"city":178,"state":143,"zip":179,"country":102,"geoPoint":180},"Advanced Research Institute, Inc","New Port Richey","34653",{"lat":181,"lon":182},28.24418,-82.71927,{"facility":184,"city":185,"state":143,"zip":186,"country":102,"geoPoint":187},"Covenant Research and Clinics, 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Deaconess","02215",{"lat":256,"lon":257},{"facility":263,"city":264,"state":265,"zip":266,"country":102,"geoPoint":267},"Mayo Clinic","Rochester","Minnesota","55905",{"lat":268,"lon":269},44.02163,-92.4699,{"facility":271,"city":272,"state":273,"zip":274,"country":102,"geoPoint":275},"Jackson Liver and GI Specialists","Jackson","Mississippi","39216",{"lat":276,"lon":277},32.29876,-90.18481,{"facility":279,"city":280,"state":281,"zip":282,"country":102,"geoPoint":283},"CHI Health Clinic (Alegent Creighton Clinic)- Gastroenterology-Bergan","Omaha","Nebraska","68124",{"lat":284,"lon":285},41.25626,-95.94043,{"facility":287,"city":288,"state":289,"zip":290,"country":102,"geoPoint":291},"Virtua Center for Liver Disease-Camden","Camden","New Jersey","08103",{"lat":292,"lon":293},39.92595,-75.11962,{"facility":295,"city":296,"state":297,"zip":298,"country":102,"geoPoint":299},"Montefiore Medical Center","The Bronx","New York","10467",{"lat":300,"lon":301},40.84985,-73.86641,{"facility":303,"city":304,"state":305,"zip":306,"country":102,"geoPoint":307},"Science 37, Inc (Remote-homebased Telemedicine)","Morrisville","North Carolina","27560",{"lat":308,"lon":309},35.82348,-78.82556,{"facility":311,"city":312,"state":313,"zip":314,"country":102,"geoPoint":315},"Cleveland Clinic - Main Campus","Cleveland","Ohio","44195",{"lat":316,"lon":317},41.4995,-81.69541,{"facility":319,"city":320,"state":321,"zip":322,"country":102,"geoPoint":323},"Einstein Healthcare Network - Einstein Medical Center","Philadelphia","Pennsylvania","19141",{"lat":324,"lon":325},39.95238,-75.16362,{"facility":327,"city":328,"state":329,"zip":330,"country":102,"geoPoint":331},"Methodist Le Bonheur Healthcare","Memphis","Tennessee","38104",{"lat":332,"lon":333},35.14953,-90.04898,{"facility":335,"city":336,"state":329,"zip":337,"country":102,"geoPoint":338},"Galen Medical Group, P.C","Tennessee City","37343",{"lat":339,"lon":340},36.09312,-87.51474,{"facility":342,"city":343,"state":344,"zip":345,"country":102,"geoPoint":346},"Amel Med LLC","Austin","Texas","78750",{"lat":347,"lon":348},30.26715,-97.74306,{"facility":350,"city":351,"state":344,"zip":352,"country":102,"geoPoint":353},"The Liver Institute at Methodist Dallas Medical Center","Dallas","75203",{"lat":354,"lon":355},32.78306,-96.80667,{"facility":357,"city":358,"state":344,"zip":359,"country":102,"geoPoint":360},"Soma Clinical Trials","Denison","75020",{"lat":361,"lon":362},33.75566,-96.53666,{"facility":364,"city":365,"state":344,"zip":366,"country":102,"geoPoint":367},"Baylor College of Medicine","Houston","77030",{"lat":368,"lon":369},29.76328,-95.36327,{"facility":371,"city":365,"state":344,"zip":366,"country":102,"geoPoint":372},"Liver Associates of Texas",{"lat":368,"lon":369},{"facility":374,"city":375,"state":344,"zip":376,"country":102,"geoPoint":377},"Impact Research","Waco","76710",{"lat":378,"lon":379},31.54933,-97.14667,{"facility":381,"city":382,"state":383,"zip":384,"country":102,"geoPoint":385},"University of Utah Health Care","Salt Lake City","Utah","84132",{"lat":386,"lon":387},40.76078,-111.89105,{"facility":389,"city":390,"state":391,"zip":392,"country":102,"geoPoint":393},"MedStar Health Research Institute","Fairfax","Virginia","22031",{"lat":394,"lon":395},38.84622,-77.30637,{"facility":397,"city":398,"state":391,"zip":399,"country":102,"geoPoint":400},"Bon Secours Liver Institute of Hampton Roads Mary Immaculate Hospital","Newport News","23602",{"lat":401,"lon":402},36.98038,-76.42975,{"facility":404,"city":405,"state":391,"zip":406,"country":102,"geoPoint":407},"Bon Secours Richmond Community Hospital LLC d\u002Fb\u002Fa Bon Secours Liver Institute of Richmond","Richmond","23226",{"lat":408,"lon":409},37.55376,-77.46026,{"facility":411,"city":412,"state":413,"zip":414,"country":102,"geoPoint":415},"Liver Institute Northwest","Seattle","Washington","98105",{"lat":416,"lon":417},47.60621,-122.33207,{"facility":419,"city":420,"state":421,"zip":422,"country":423,"geoPoint":424},"Hospital de Alta Complejidad En Red El Cruce","San Juan Bautista","Buenos Aires","1888","Argentina",{"lat":425,"lon":426},-34.80896,-58.27623,{"facility":428,"city":429,"state":430,"zip":431,"country":423,"geoPoint":432},"Hospital Provincial Del Centenario","Rosario","Santa Fe Province","2000",{"lat":433,"lon":434},-32.94682,-60.63932,{"facility":436,"city":437,"zip":438,"country":423},"Glenny Corp S.A","CABA","1430",{"facility":440,"city":441,"zip":442,"country":423,"geoPoint":443},"Clínica de Nefrología, Urología y Enfermedades Cardiovasculares","Santa Fe","3000",{"lat":444,"lon":445},-31.64881,-60.70868,{"facility":447,"city":448,"zip":449,"country":450,"geoPoint":451},"Universitair Ziekenhuis Antwerpe UZA","Antwerp","2650","Belgium",{"lat":452,"lon":453},51.22047,4.40026,{"facility":455,"city":456,"zip":457,"country":450,"geoPoint":458},"Cliniques Universitaires Saint-Luc","Brussels","1200",{"lat":459,"lon":460},50.85045,4.34878,{"facility":462,"city":463,"zip":464,"country":450,"geoPoint":465},"UZ Gent","Ghent","9000",{"lat":466,"lon":467},51.05,3.71667,{"facility":469,"city":470,"state":471,"zip":472,"country":473,"geoPoint":474},"Centro de Pesquisa Clínica da Bahiana Saúde","Salvador","Estado de Bahia","40290-000","Brazil",{"lat":475,"lon":476},-12.97563,-38.49096,{"facility":478,"city":479,"state":480,"zip":481,"country":473,"geoPoint":482},"Hospital Das Clínicas Da Ufg","Goiânia","Goiás","74605-050",{"lat":483,"lon":484},-16.67861,-49.25389,{"facility":486,"city":487,"state":488,"zip":489,"country":473,"geoPoint":490},"Centro de Pesquisas Clínicas do HC\u002FUFMG-EBSERH","Belo Horizonte","Minas Gerais","30130-100",{"lat":491,"lon":492},-19.92083,-43.93778,{"facility":494,"city":495,"state":496,"zip":497,"country":473,"geoPoint":498},"Hospital de Clínicas de Porto Alegre","Porto Alegre","Rio Grande do Sul","90035903",{"lat":499,"lon":500},-30.03283,-51.23019,{"facility":502,"city":503,"zip":504,"country":473,"geoPoint":505},"Hospital Universitário Clementino Fraga Filho - Secretaria de Hepatologia","Rio de Janeiro","21941-617",{"lat":506,"lon":507},-22.90642,-43.18223,{"facility":509,"city":503,"zip":510,"country":473,"geoPoint":511},"Instituto de Educação, Pesquisa e Gestão em Saúde","22775-001",{"lat":506,"lon":507},{"facility":513,"city":514,"zip":515,"country":473,"geoPoint":516},"Fundação Oswaldo Ramos","São Paulo","04038-002",{"lat":517,"lon":518},-23.5475,-46.63611,{"facility":520,"city":521,"state":522,"zip":523,"country":524,"geoPoint":525},"Gordon and Leslie Diamond Health Care Centre, Division of Gastroenterology","Vancouver","British Columbia","V5Z 1M9","Canada",{"lat":526,"lon":527},49.24966,-123.11934,{"facility":529,"city":521,"state":522,"zip":530,"country":524,"geoPoint":531},"(G.I.R.I.) GI Research Institute Foundation","V6Z 2K5",{"lat":526,"lon":527},{"facility":533,"city":534,"state":535,"zip":536,"country":524,"geoPoint":537},"McMaster University Medical Center","Hamilton","Ontario","L8S 4K1",{"lat":538,"lon":539},43.25011,-79.84963,{"facility":541,"city":542,"state":535,"zip":543,"country":524,"geoPoint":544},"University Hospital, LHSC","London","N6A5A5",{"lat":545,"lon":546},42.98339,-81.23304,{"facility":548,"city":549,"state":535,"zip":550,"country":524,"geoPoint":551},"Toronto General Hospital","Toronto","M5G 1Z5",{"lat":552,"lon":553},43.70643,-79.39864,{"facility":555,"city":556,"state":557,"zip":558,"country":524,"geoPoint":559},"McGill University Health Centre","Montreal","Quebec","H4A 3J1",{"lat":560,"lon":561},45.50884,-73.58781,{"facility":563,"city":564,"zip":565,"country":524,"geoPoint":566},"University of Alberta","Edmonton","T6G 2X8",{"lat":567,"lon":568},53.55014,-113.46871,{"facility":570,"city":556,"zip":571,"country":524,"geoPoint":572},"CRCHUM (Centre de Recherche du Centre Hospitalier de l'Université de Montréal)","H2X 0A9",{"lat":560,"lon":561},{"facility":574,"city":575,"state":576,"zip":577,"country":578,"geoPoint":579},"Mengchao Hepatobiliary Hospital of Fujian Medical University","Fuzhou","Fujian","350028","China",{"lat":580,"lon":581},26.06139,119.30611,{"facility":583,"city":584,"state":585,"zip":586,"country":578,"geoPoint":587},"Union Hospital Tongji Medical College Huazhong University of Science and Technology","Wuhan","Hubei","430022",{"lat":588,"lon":589},30.58333,114.26667,{"facility":591,"city":592,"state":593,"zip":594,"country":578,"geoPoint":595},"The First Hospital of Jilin University","Changchun","Jilin","130031",{"lat":596,"lon":597},43.88,125.32278,{"facility":599,"city":600,"state":601,"zip":602,"country":578,"geoPoint":603},"The First Affiliated Hospital, Zhejiang University School of Medicine","Hangzhou","Zhejiang","310003",{"lat":604,"lon":605},30.29365,120.16142,{"facility":607,"city":608,"zip":609,"country":578,"geoPoint":610},"Beijing Youan Hospital, Capital Medical University","Beijing","100069",{"lat":611,"lon":612},39.9075,116.39723,{"facility":614,"city":608,"zip":615,"country":578,"geoPoint":616},"Beijing Friendship Hospital, Capital Medical University","10050",{"lat":611,"lon":612},{"facility":618,"city":600,"zip":619,"country":578,"geoPoint":620},"Sir Run Run Shaw Hospital -Zhejiang University School of Medicine","310009",{"lat":604,"lon":605},{"facility":622,"city":623,"zip":624,"country":625,"geoPoint":626},"CHU Grenoble - Hôpital MICHALLON","Grenoble","38043","France",{"lat":627,"lon":628},45.17869,5.71479,{"facility":630,"city":631,"zip":632,"country":625,"geoPoint":633},"Hopital Claude Huriez-Digestive system disease clinic","Lille","59037",{"lat":634,"lon":635},50.63391,3.05512,{"facility":637,"city":638,"zip":639,"country":625,"geoPoint":640},"CHU de NICE- Hospital L'Archet 2","Nice","06202",{"lat":641,"lon":642},43.70313,7.26608,{"facility":644,"city":645,"zip":646,"country":625,"geoPoint":647},"Hospital Saint Antoine","Paris","75012",{"lat":648,"lon":649},48.85341,2.3488,{"facility":651,"city":652,"zip":653,"country":625,"geoPoint":654},"Nouvel Hospital Civil","Strasbourg","67091",{"lat":655,"lon":656},48.58392,7.74553,{"facility":658,"city":659,"zip":660,"country":625,"geoPoint":661},"Hospital Paul Brousse- APHP","Villejuif","94800",{"lat":662,"lon":663},48.7939,2.35992,{"facility":665,"city":666,"zip":667,"country":668,"geoPoint":669},"Klinikum Chemnitz gGmbH","Chemnitz","09116","Germany",{"lat":670,"lon":671},50.8357,12.92922,{"facility":673,"city":674,"country":668,"geoPoint":675},"Universitätsklinikum Frankfurt am Main","Frankfurt",{"lat":676,"lon":677},49.68333,10.53333,{"facility":679,"city":680,"zip":681,"country":668,"geoPoint":682},"Medizinische Hochschule Hannover (MHH)","Hanover","30625",{"lat":683,"lon":684},52.37052,9.73322,{"facility":686,"city":687,"zip":688,"country":668,"geoPoint":689},"Universitätsklinikum Schleswig-Holstein","Kiel","24105",{"lat":690,"lon":691},54.32133,10.13489,{"facility":693,"city":694,"zip":695,"country":668,"geoPoint":696},"Universitätsklinikum Leipzig, Klinik und Poliklinik für Onkologie, Gastroenterologie, Hepatologie und Pneumologie","Leipzig","04103",{"lat":697,"lon":698},51.33962,12.37129,{"facility":700,"city":701,"zip":702,"country":668,"geoPoint":703},"Otto-von-Guericke-Universität Klinik für Gastroenterologie, Hepatologie und Infektiologie Universitätsklinikum Magdeburg A.ö.R.","Magdeburg","39120",{"lat":704,"lon":705},52.13129,11.63189,{"facility":707,"city":708,"zip":709,"country":668,"geoPoint":710},"University Hospital Munster","Münster","48149",{"lat":711,"lon":712},51.96236,7.62571,{"facility":714,"city":715,"zip":716,"country":668,"geoPoint":717},"University Hospital Tübingen Medical clinic","Tübingen","72076",{"lat":718,"lon":719},48.52266,9.05222,{"facility":721,"city":722,"zip":723,"country":668,"geoPoint":724},"St. Josefs-Hospital Wiesbaden","Wiesbaden","65189",{"lat":725,"lon":726},50.08601,8.24435,{"facility":728,"city":729,"zip":730,"country":731,"geoPoint":732},"Hillel Yaffe Medical Center","Hadera","3810101","Israel",{"lat":733,"lon":734},32.44192,34.9039,{"facility":736,"city":737,"zip":738,"country":731,"geoPoint":739},"Rambam Medical Center","Haifa","3109601",{"lat":740,"lon":741},32.81303,34.99928,{"facility":743,"city":737,"zip":744,"country":731,"geoPoint":745},"Carmel Medical Center","3434104",{"lat":740,"lon":741},{"facility":747,"city":748,"zip":749,"country":731,"geoPoint":750},"Shaare Zedek Medical Center","Jerusalem","9103102",{"lat":751,"lon":752},31.76904,35.21633,{"facility":754,"city":748,"zip":755,"country":731,"geoPoint":756},"Hadassah Medical Center - Ein Karem, Liver Institute Kiryat Hadassah POB 12000","9112001",{"lat":751,"lon":752},{"facility":758,"city":759,"zip":760,"country":731,"geoPoint":761},"Galilee Medical Center","Nahariya","2210001",{"lat":762,"lon":763},33.00892,35.09814,{"facility":765,"city":766,"zip":767,"country":731,"geoPoint":768},"Rabin Medical Center","Petah Tikva","4941492",{"lat":769,"lon":770},32.08707,34.88747,{"facility":772,"city":773,"zip":774,"country":731,"geoPoint":775},"Sheba Medical Center","Ramat Gan","52621",{"lat":776,"lon":777},32.08227,34.81065,{"facility":779,"city":780,"zip":781,"country":731,"geoPoint":782},"The Tel Aviv Sourasky Medical Center","Tel Aviv","6423906",{"lat":783,"lon":784},32.08088,34.78057,{"facility":786,"city":787,"country":788,"geoPoint":789},"Universita Politecnica delle Marche- Ospedali Riuniti","Ancona","Italy",{"lat":790,"lon":791},43.60717,13.5103,{"facility":793,"city":794,"zip":795,"country":788,"geoPoint":796},"ASST Papa Giovanni XXIII","Bergamo","24127",{"lat":797,"lon":798},45.69601,9.66721,{"facility":800,"city":801,"zip":802,"country":788,"geoPoint":803},"Fondazione Ca Granda","Milan","20122",{"lat":804,"lon":805},42.78235,12.59836,{"facility":807,"city":801,"zip":808,"country":788,"geoPoint":809},"ASST Grande Ospedale Metropolitano Niguarda","20162",{"lat":804,"lon":805},{"facility":811,"city":812,"zip":813,"country":788,"geoPoint":814},"Azienda Ospedaliero Universitaria Di Modena","Modena","41126",{"lat":815,"lon":816},44.64783,10.92539,{"facility":818,"city":819,"zip":820,"country":788,"geoPoint":821},"Fondazione IRCCS San Gerardo dei Tintori","Monza","20900",{"lat":822,"lon":823},45.58005,9.27246,{"facility":825,"city":826,"zip":827,"country":788,"geoPoint":828},"Azienda Ospedale-Università di Padova","Padova","35128",{"lat":829,"lon":830},44.38225,11.14261,{"facility":832,"city":833,"zip":834,"country":788,"geoPoint":835},"Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone","Palermo","90127",{"lat":836,"lon":837},38.1166,13.3636,{"facility":839,"city":840,"zip":841,"country":788,"geoPoint":842},"Azienda Ospedaliero Universitaria Pisana (AOUP)","Pisa","56124",{"lat":843,"lon":844},43.70853,10.4036,{"facility":846,"city":847,"country":788,"geoPoint":848},"Istituto Clinico Humanitas","Rozzano",{"lat":849,"lon":850},45.38193,9.1559,{"facility":852,"city":853,"state":854,"zip":855,"country":856,"geoPoint":857},"National Hospital Organization Nagasaki Medical Center","Ōmura","Nagasaki","856-8562","Japan",{"lat":858,"lon":859},32.92139,129.95389,{"facility":861,"city":862,"zip":863,"country":856},"Ehime University Hospital","Ehime","791-0295",{"facility":865,"city":866,"zip":867,"country":856},"Teine Keijinkai Hospital","Hokkaido","006-8555",{"facility":869,"city":870,"zip":871,"country":856,"geoPoint":872},"Osaka Rosai Hospital","Osaka","591-8025",{"lat":873,"lon":874},34.69379,135.50107,{"facility":876,"city":877,"zip":878,"country":856,"geoPoint":879},"Toranomon Hospital","Tokyo","105-8470",{"lat":880,"lon":881},35.6895,139.69171,{"facility":883,"city":884,"zip":885,"country":886,"geoPoint":887},"Amstedam University Medical Centers","Amsterdam","1081 HV","Netherlands",{"lat":888,"lon":889},52.37403,4.88969,{"facility":891,"city":892,"zip":893,"country":886,"geoPoint":894},"Radboudumc","Nijmegen","6525 GA",{"lat":895,"lon":896},51.8425,5.85278,{"facility":898,"city":899,"country":886,"geoPoint":900},"Erasmus medical center","Rotterdam",{"lat":901,"lon":902},51.9225,4.47917,{"facility":904,"city":905,"zip":906,"country":907,"geoPoint":908},"Hospital Universitari Vall d' Hebron","Barcelona","08035","Spain",{"lat":909,"lon":910},41.38879,2.15899,{"facility":912,"city":905,"zip":913,"country":907,"geoPoint":914},"Hospital Clínic de Barcelona","08036",{"lat":909,"lon":910},{"facility":916,"city":905,"zip":917,"country":907,"geoPoint":918},"Hospital Universitari Parc Tauli","08208",{"lat":909,"lon":910},{"facility":920,"city":921,"zip":922,"country":907,"geoPoint":923},"Hospital General Universitario Gregorio Maranon","Madrid","28007",{"lat":924,"lon":925},40.4165,-3.70256,{"facility":927,"city":928,"zip":929,"country":907,"geoPoint":930},"Hospital Universitario Virgen del Rocio","Seville","41013",{"lat":931,"lon":932},37.38283,-5.97317,{"facility":934,"city":935,"zip":936,"country":907,"geoPoint":937},"Hospital Universitario Miguel Servet","Zaragoza","50009",{"lat":938,"lon":939},41.65606,-0.87734,{"facility":941,"city":942,"zip":943,"country":944,"geoPoint":945},"Ente Ospedaliero Cantonale","Lugano","6900","Switzerland",{"lat":946,"lon":947},46.01008,8.96004,{"facility":949,"city":950,"zip":951,"country":944,"geoPoint":952},"University Hospital Zurich(USZ)","Zurich","8091",{"lat":953,"lon":954},47.36667,8.55,{"facility":956,"city":957,"state":958,"zip":959,"country":960,"geoPoint":961},"University Hospital Southampton NHS Foundation Trust","Southampton","Hampshire","S016 6YD","United Kingdom",{"lat":962,"lon":963},50.90395,-1.40428,{"facility":965,"city":966,"state":967,"zip":968,"country":960,"geoPoint":969},"University Hospitals Birmingham NHS Foundation Trust of Trust Headquarters","Birmingham","West Midlands","B15 2GW",{"lat":970,"lon":971},52.48142,-1.89983,{"facility":973,"city":974,"zip":975,"country":960,"geoPoint":976},"Belfast Health & Social Care Trust (BHSCT) Royal Victoria Hospital","Belfast","BT12 6BA",{"lat":977,"lon":978},54.59682,-5.92541,{"facility":980,"city":542,"zip":981,"country":960,"geoPoint":982},"Royal Free Hospital NHS Foundation Trust","NW3 2QZ",{"lat":983,"lon":984},51.50853,-0.12574,{"facility":986,"city":542,"zip":987,"country":960,"geoPoint":988},"King's College Hospital NHS Foundation Trust","SE5 9RS",{"lat":983,"lon":984},{"facility":990,"city":991,"zip":992,"country":960,"geoPoint":993},"Freeman Hospital","Newcastle upon Tyne","NE7 7DN",{"lat":994,"lon":995},54.97328,-1.61396,{"facility":997,"city":998,"country":960,"geoPoint":999},"Nottingham University Hospitals NHS Trust","Nottingham",{"lat":1000,"lon":1001},52.9536,-1.15047,[],[],[1005],{"pmid":1006,"type":1007,"citation":1008},"40439725","DERIVED","Klatzkow H, Bhavsar-Burke I, Pearson M, Wentworth BJ. Primary Biliary Cholangitis in 2025: A New Frontier. Am J Gastroenterol. 2025 Dec 1;120(12):2746-2749. doi: 10.14309\u002Fajg.0000000000003559. Epub 2025 May 29. No abstract available.",[],{"nct_id":4,"conditions":1011,"biomarkers":1013},[1012,22],"Primary Biliary Cirrhosis",[],{"nct_id":4,"found":15,"summary":1015,"prompt_version":1025},{"design":1016,"status":1017,"heading":1018,"summary":1019,"follow_up":1020,"word_count":1021,"commitments":1022,"compensation":1023,"drugs_mentioned":1024},"This study is testing volixibat against a placebo in about 260 participants. It is an interventional study, meaning participants will receive either the active drug or a placebo.","completed","Volixibat for Itching Caused by Primary Biliary Cholangitis","This study is testing an investigational drug called volixibat to see if it can help reduce itching (pruritus) in people with Primary Biliary Cholangitis (PBC). Volixibat is an Ileal Bile Acid Transporter (IBAT) inhibitor, meaning it works by affecting how bile acids are handled in your body. You might be able to join if you are at least 18 years old and have a confirmed diagnosis of PBC. The main goal is to measure how much your daily itch scores change over 28 weeks while taking volixibat compared to a placebo (an inactive capsule). The study is currently unclear on its recruitment status and plans to enroll about 260 participants.","The primary endpoint is measured at week 28, suggesting follow-up will occur at least until this time point.",110,"You will need to provide signed informed consent and attend all study visits and requirements through the end of the study.","Not stated in the trial record.",[36,45],"v2"]