[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05426733":3,"trial-entities:NCT05426733":298,"trial-summary:NCT05426733":301},{"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":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":37,"secondary_outcomes":41,"sex":65,"minimum_age":66,"maximum_age":66,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":78,"locations":82,"central_contacts":294,"overall_officials":295,"references":296,"see_also_links":297},"NCT05426733","A4250-016","An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat in Children With Biliary Atresia","An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children With Biliary Atresia (BOLD-EXT)","ENROLLING_BY_INVITATION","2028-06-30","2026-07","2026-07-02","2022-07-05","Albireo, an Ipsen Company","INDUSTRY",true,"An Open-label Extension Study to Evaluate Long-term Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia","This is a Phase 3, multi-center, open-label extension study to evaluate the long-term efficacy and safety of odevixibat in patients with Biliary Atresia (BA). Patients who completed treatment in the A4250-011 BOLD study and meet eligibility criteria for Study A4250-016 (BOLD-EXT) can participate. The duration of the treatment period is 104 weeks, followed by a 4-week Safety Follow-up Period. Patients who wish to continue receiving odevixibat after 104 weeks can remain on treatment in the optional extension period (OEP).\n\nUp to 180 patients will be enrolled at approximately 70 sites in the North America, Europe, the Middle East and Asia-Pacific.",[19],"Biliary Atresia",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE3",{"count":26,"type":27},180,"ESTIMATED",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Odevixibat","Odevixibat is a small molecule inhibitor of the ileal bile acid transporter (IBAT).",[34],"Odevixibat (A4250)",[36],"A4250",[38],{"measure":39,"timeFrame":40},"Proportion of patients who are alive and have not undergone liver transplant","From baseline to Week 104",[42,45,48,51,54,56,59,62],{"measure":43,"description":44,"timeFrame":40},"Change in aspartate aminotransferase (AST) to platelet ratio index (APRI) score","The APRI (aspartate aminotransferase to platelet ratio index) score estimates the severity of liver fibrosis. A higher score indicates a greater amount of scarring (fibrosis) in the liver.\n\n* A score ≤ 0.5 indicates a low likelihood of fibrosis\n* A score ≥ 1.5 indicates a higher probability of fibrosis",{"measure":46,"description":47,"timeFrame":40},"Change in Fibrosis-4 (Fib-4) score","The Fib-4 score provides an estimate of the amount of scarring (fibrosis) in the liver. A higher score indicates a greater amount of scarring in the liver.\n\n* A score \\\u003C 1.45 indicates a low likelihood of fibrosis\n* A score \\> 3.25 indicates a higher probability of fibrosis",{"measure":49,"timeFrame":50},"Change in serum bile acids","From Baseline to Weeks 26, 52, 78, and 104",{"measure":52,"timeFrame":53},"Change in height","From Baseline to Weeks 26, 52, 78 and 104",{"measure":55,"timeFrame":53},"Change in weight",{"measure":57,"description":58,"timeFrame":53},"Change in mid-arm circumference","Measure of growth",{"measure":60,"timeFrame":61},"Time to onset of any sentinel events","From Baseline to Week 104",{"measure":63,"description":64,"timeFrame":53},"Change in pediatric end-stage liver disease (PELD) score","The PELD (pediatric end-stage liver disease) score is a measure of disease severity. PELD scores can range from a negative value (such as -10) to high numbers (such as 45). A higher score indicates more severe disease.","ALL",null,false,{"inclusion":69,"exclusion":72,"raw_text":77},[70,71],"Completion of the 104-week Treatment Period of Study A4250-011","Signed informed consent by caregiver",[73,74,75,76],"Patients who were not compliant with study drug treatment or procedures in Study A4250-011 as per the investigator's discretion","Any conditions or abnormalities which, in the opinion of the investigator, may compromise the safety of the patient, or interfere with the patient participating in or completing the study","Known hypersensitivity to any components of odevixibat","Patients who are scheduled for a liver transplant or are likely to require a liver transplant in the immediate future based on the investigator's judgment","Inclusion Criteria:\n\n* Completion of the 104-week Treatment Period of Study A4250-011\n* Signed informed consent by caregiver\n\nExclusion Criteria:\n\n* Patients who were not compliant with study drug treatment or procedures in Study A4250-011 as per the investigator's discretion\n* Any conditions or abnormalities which, in the opinion of the investigator, may compromise the safety of the patient, or interfere with the patient participating in or completing the study\n* Known hypersensitivity to any components of odevixibat\n* Patients who are scheduled for a liver transplant or are likely to require a liver transplant in the immediate future based on the investigator's judgment",[79,80,81],"CHILD","ADULT","OLDER_ADULT",[83,92,100,108,116,124,131,135,142,150,158,166,173,179,186,192,199,206,212,219,225,232,239,246,254,261,268,275,282,288],{"facility":84,"city":85,"state":86,"zip":87,"country":88,"geoPoint":89},"Children's Hospital Colorado","Aurora","Colorado","80045","United States",{"lat":90,"lon":91},39.72943,-104.83192,{"facility":93,"city":94,"state":95,"zip":96,"country":88,"geoPoint":97},"Children's Healhcare of Atlanta- Emory University school of medicine","Atlanta","Georgia","30322",{"lat":98,"lon":99},33.749,-84.38798,{"facility":101,"city":102,"state":103,"zip":104,"country":88,"geoPoint":105},"Indiana University school of Medicine","Indianapolis","Indiana","46202",{"lat":106,"lon":107},39.76838,-86.15804,{"facility":109,"city":110,"state":111,"zip":112,"country":88,"geoPoint":113},"Boston Children's Hospital","Boston","Massachusetts","02115",{"lat":114,"lon":115},42.35843,-71.05977,{"facility":117,"city":118,"state":119,"zip":120,"country":88,"geoPoint":121},"Children's Mercy Hospital and Clinics","Kansas City","Missouri","64108",{"lat":122,"lon":123},39.09973,-94.57857,{"facility":125,"city":126,"state":126,"zip":127,"country":88,"geoPoint":128},"Hassenfeld Children's Hospital at NYU Langone","New York","10016",{"lat":129,"lon":130},40.71427,-74.00597,{"facility":132,"city":126,"state":126,"zip":133,"country":88,"geoPoint":134},"Columbia University Medical Center New York Presbyterian Morgan Stanley-Komansky Childrens Hospital","10032",{"lat":129,"lon":130},{"facility":136,"city":137,"state":126,"zip":138,"country":88,"geoPoint":139},"The Childrens Hospital at Montefiore Albert Einstein School of Medicine","The Bronx","10467",{"lat":140,"lon":141},40.84985,-73.86641,{"facility":143,"city":144,"state":145,"zip":146,"country":88,"geoPoint":147},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",{"lat":148,"lon":149},39.12711,-84.51439,{"facility":151,"city":152,"state":153,"zip":154,"country":88,"geoPoint":155},"Seattle Children's Hospital","Seattle","Washington","98105",{"lat":156,"lon":157},47.60621,-122.33207,{"facility":159,"city":160,"zip":161,"country":162,"geoPoint":163},"Royal Children's Hospital","Parkville","3052","Australia",{"lat":164,"lon":165},-37.78333,144.95,{"facility":167,"city":168,"country":169,"geoPoint":170},"CHU Sainte-Justine","Montreal","Canada",{"lat":171,"lon":172},45.50884,-73.58781,{"facility":174,"city":175,"country":169,"geoPoint":176},"The Hospital for Sick Children","Toronto",{"lat":177,"lon":178},43.70643,-79.39864,{"facility":180,"city":181,"country":182,"geoPoint":183},"Guangzhou Women And Childrens Medical Center","Guangdong","China",{"lat":184,"lon":185},42.76832,129.33635,{"facility":187,"city":188,"country":182,"geoPoint":189},"Children's Hospital of Fudan University","Shanghai",{"lat":190,"lon":191},31.22222,121.45806,{"facility":193,"city":194,"country":195,"geoPoint":196},"Bicêtre Hospital","Le Kremlin-Bicêtre","France",{"lat":197,"lon":198},48.81471,2.36073,{"facility":200,"city":201,"country":202,"geoPoint":203},"Charité - Universitätsmedizin Berlin","Berlin","Germany",{"lat":204,"lon":205},52.52437,13.41053,{"facility":207,"city":208,"country":202,"geoPoint":209},"University Children´s Hospital Tuebingen","Tübingen",{"lat":210,"lon":211},48.52266,9.05222,{"facility":213,"city":214,"country":215,"geoPoint":216},"ASST Papa Giovanni XXIII","Bergamo","Italy",{"lat":217,"lon":218},45.69601,9.66721,{"facility":220,"city":221,"country":215,"geoPoint":222},"Azienda Ospedaliera di Padova","Padova",{"lat":223,"lon":224},44.38225,11.14261,{"facility":226,"city":227,"country":228,"geoPoint":229},"Hospital Raja Perempuan Zainab II","Kota Bharu","Malaysia",{"lat":230,"lon":231},6.12361,102.24333,{"facility":233,"city":234,"zip":235,"country":228,"geoPoint":236},"University Malaya Medical Centre","Kuala Lumpur","59100",{"lat":237,"lon":238},3.1412,101.68653,{"facility":240,"city":241,"country":242,"geoPoint":243},"University Medical Center Groningen","Groningen","Netherlands",{"lat":244,"lon":245},53.21917,6.56667,{"facility":247,"city":248,"zip":249,"country":250,"geoPoint":251},"Starship Child Health, Te Whatu Ora - Health New Zealand","Auckland","1023","New Zealand",{"lat":252,"lon":253},-36.84853,174.76349,{"facility":255,"city":256,"country":257,"geoPoint":258},"Instytut Pomnik-Centrum Zdrowia Dziecka","Warsaw","Poland",{"lat":259,"lon":260},52.22977,21.01178,{"facility":262,"city":263,"country":264,"geoPoint":265},"Seoul National University Childrens Hospital","Seoul","South Korea",{"lat":266,"lon":267},37.566,126.9784,{"facility":269,"city":270,"country":271,"geoPoint":272},"Hospital Universitari Vall d'Hebron","Barcelona","Spain",{"lat":273,"lon":274},41.38879,2.15899,{"facility":276,"city":277,"country":278,"geoPoint":279},"Hacettepe İhsan Doğramacı Children's Hospital","Ankara","Turkey (Türkiye)",{"lat":280,"lon":281},39.91987,32.85427,{"facility":283,"city":284,"country":278,"geoPoint":285},"Akdeniz University Medical Faculty","Antalya",{"lat":286,"lon":287},36.90812,30.69556,{"facility":289,"city":290,"country":278,"geoPoint":291},"Istanbul University Istanbul Medical Faculty Hospital","Istanbul",{"lat":292,"lon":293},41.01384,28.94966,[],[],[],[],{"nct_id":4,"conditions":299,"biomarkers":300},[19],[],{"nct_id":4,"found":67,"summary":66,"prompt_version":66}]