[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640181":3},{"organization":4,"armGroups":7,"interventions":7,"overallOfficials":8,"centralContacts":12,"locations":18,"responsibleParty":48,"collaborators":7,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":7,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":7,"enrollmentInfo":59,"targetDuration":62,"studyType":63,"phases":7,"briefSummary":64,"conditions":65,"keywords":7,"overallStatus":33,"whyStopped":7,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Ipsen","INDUSTRY",null,[9],{"name":10,"affiliation":5,"role":11},"Ipsen Medical Director","STUDY_DIRECTOR",[13],{"name":14,"role":15,"phone":16,"phoneExt":7,"email":17},"Ipsen Clinical Study Enquiries","CONTACT","See e-mail","Clinical.trials@ipsen.com",[19,31,40],{"facility":20,"status":21,"city":22,"state":7,"zip":7,"country":23,"countryCode":24,"cosmosGeoPoint":25,"geoPoint":30,"contacts":7},"Capital Children's Medical Center","ACTIVE_NOT_RECRUITING","Beijing","China","CN",{"type":26,"coordinates":27},"Point",[28,29],116.39723,39.9075,{"lat":29,"lon":28},{"facility":32,"status":33,"city":34,"state":7,"zip":7,"country":23,"countryCode":24,"cosmosGeoPoint":35,"geoPoint":39,"contacts":7},"Hunan Children's Hospital","RECRUITING","Hunan",{"type":26,"coordinates":36},[37,38],120.18021,32.92741,{"lat":38,"lon":37},{"facility":41,"status":33,"city":42,"state":7,"zip":7,"country":23,"countryCode":24,"cosmosGeoPoint":43,"geoPoint":47,"contacts":7},"Children's Hospital of Fudan University Endocrinology and Metabolism","Shanghai",{"type":26,"coordinates":44},[45,46],121.45806,31.22222,{"lat":46,"lon":45},{"type":49,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100640181","a-study-of-the-effectiveness-safety-and-the-long-term-outcomes-of-participants-with-progressive-familial-intrahepatic-cholestasis-pfic-who-take-odevixibat-bylvay-in-china-100640181",false,"NCT07588880","A Study of the Effectiveness, Safety and the Long-term Outcomes of Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay) in China","Registry to Document Treatment Effectiveness, Safety, Including Prospective Long-term Outcomes in Participants With Progressive Familial Intrahepatic Cholestasis (PFIC) Who Take Odevixibat (Bylvay).","Inclusion Criteria:\n\n* Diagnosed with PFIC (all types) who have been prescribed odevixibat (independently of the decision to enroll the participant in this registry) by their treating physician\n* On (or starting) active odevixibat treatment (participants can remain in the registry during odevixibat treatment interruptions)\n* Signed informed consent and assent, as appropriate\n\nExclusion Criteria:\n\n* Currently participating in a clinical trial with odevixibat\n* Currently participating in any interventional clinical trial for PFIC\n* Have any contraindication to odevixibat as per the approved label in China","ALL","6 Months",{"count":60,"type":61},20,"ESTIMATED","5 Years","OBSERVATIONAL","This registry-based study will collect information from people with Progressive Familial Intrahepatic Cholestasis (PFIC) who take odevixibat (Bylvay) as part of routine clinical care in China.\n\nPFIC is a rare genetic liver disease that affects bile secretion and can cause bile acids to build up in the liver, which may lead to symptoms such as severe itching (pruritus).\n\nOdevixibat was first allowed to be used for PFIC in babies older than 6 months by the European Medicines Agency (EMA) on 16 July 2021 and by the United States Food and Drug Administration (FDA) on 20 July 2021 for itching in babies older than 3 months. Odevixibat is approved for the treatment of pruritus in PFIC and was approved in China on 01 December 2024 for patients 6 months of age and older with PFIC.\n\nThe main aim of this registry is to assess long-term real-world safety (based on adverse events) and to describe effectiveness outcomes.",[66],"Progressive Familial Intrahepatic Cholestasis","2026-07-01",{"date":69,"type":70},"2026-07-02","ACTUAL",{"date":72,"type":70},"2026-04-16",{"date":74,"type":61},"2031-04-30",{"name":5,"class":6},3]