[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602338":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":13,"centralContacts":18,"locations":7,"responsibleParty":28,"collaborators":7,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":7,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":38,"maxAge":7,"enrollmentInfo":39,"targetDuration":7,"studyType":42,"phases":7,"briefSummary":43,"conditions":44,"keywords":7,"overallStatus":46,"whyStopped":7,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":7},{"fullName":5,"class":6},"Methodist Health System","OTHER",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"PROCEDURE","Blood Draws","Research-related blood draws will be used to ascertain FGF19 levels.",[14],{"name":15,"affiliation":16,"role":17},"Mangesh Pagadala, MD","Methodist Heath System","PRINCIPAL_INVESTIGATOR",[19,24],{"name":20,"role":21,"phone":22,"phoneExt":7,"email":23},"Jeffrey Wilson","CONTACT","7373332427","JeffreyWilson@mhd.com",{"name":25,"role":21,"phone":26,"phoneExt":7,"email":27},"Karshena Valsin","2149474681","KarshenaValsin@mhd.com",{"type":29,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100602338","monitoring-the-response-of-combination-ursodiol-and-seladelpar-treatment-100602338",false,"NCT07122206","Monitoring the Response of Combination Ursodiol and Seladelpar Treatment","Monitoring the Response of Combination Ursodiol and Seladelpar Treatment in Primary Biliary Cholangitis Using Invasive Markers","Inclusion Criteria:\n\n* Patients must have a confirmed diagnosis PBC as per established diagnostic criteria.\n* Adults aged 18 years and older.\n* Patients undergoing treatment with ursodiol (ursodeoxycholic acid) for PBC or who demonstrate intolerance to ursodiol due to side effects and persistent ALP \\> normal.\n* Patients undergoing treatment with seladelpar for PBC.\n* Patients must be willing and able to provide written informed consent for participation in the study.\n\nExclusion Criteria:\n\n* Patients that do not meet inclusion criteria.\n* Patients with other chronic liver diseases, such as hepatitis B, hepatitis C, non-alcoholic steatohepatitis (NASH), alcoholic liver disease, or other autoimmune liver diseases.\n* Patients who have undergone a liver transplant.\n* Presence of cirrhosis or hepatic decompensation at the time of study enrollment.\n* Patients with significant comorbid conditions that may interfere with the study outcomes, such as severe cardiovascular, renal, or pulmonary diseases.\n* Pregnant or breastfeeding women, due to potential risks to the fetus or infant.\n* Inability or unwillingness to comply with the study protocol, including scheduled visits, tests, and procedures.","ALL","18 Years",{"count":40,"type":41},100,"ESTIMATED","OBSERVATIONAL","This study aims to provide comprehensive insights into the therapeutic effects of combination treatment with ursodiol and seladelpar in PBC patients by assessing biochemical responses using biomarkers such as ALP and total bilirubin.",[45],"Primary Biliary Cholangitis","NOT_YET_RECRUITING","2025-08-07",{"date":49,"type":50},"2025-08-14","ACTUAL",{"date":52,"type":41},"2025-08",{"date":54,"type":41},"2027-08",{"name":5,"class":6}]