[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100497032":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":47,"responsibleParty":147,"collaborators":41,"id":150,"slug":151,"hasResults":152,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":41,"eligibilityCriteria":156,"healthyVolunteers":152,"sex":157,"minAge":158,"maxAge":159,"enrollmentInfo":160,"targetDuration":41,"studyType":163,"phases":164,"briefSummary":166,"conditions":167,"keywords":41,"overallStatus":50,"whyStopped":41,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},{"fullName":5,"class":6},"Xijing Hospital of Digestive Diseases","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo","PLACEBO_COMPARATOR","1 tablet\u002F day",[13],"Drug: Placebo Combined With Ursodeoxycholic Acid",{"label":15,"type":16,"description":17,"interventionNames":18},"Fenofibrate","EXPERIMENTAL","200 mg\u002Fday",[19],"Drug: Fenofibrate Combined With Ursodeoxycholic Acid",[21,27],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Placebo Combined With Ursodeoxycholic Acid",[9],[26],"UDCA 13-15mg\u002Fkg\u002Fd",{"type":22,"name":28,"description":17,"armGroupLabels":29,"otherNames":30},"Fenofibrate Combined With Ursodeoxycholic Acid",[15],[26],[32],{"name":33,"affiliation":34,"role":35},"Ying Han, Doctor","The First Affiliated Hospital of Air Force Medicial University","PRINCIPAL_INVESTIGATOR",[37,43],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Yulong Shang","CONTACT","+86 18629661032",null,"shangyl870222@163.com",{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},"Ying Han","+86-29-84771539","hanying1@fmmu.edu.cn",[48,66,81,94,108,120,134],{"facility":49,"status":50,"city":51,"state":52,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"The second hospital of Lanzhou University","RECRUITING","Lanzhou","Gansu","China","CN",{"type":56,"coordinates":57},"Point",[58,59],103.83987,36.05701,{"lat":59,"lon":58},[62],{"name":63,"role":39,"phone":64,"phoneExt":41,"email":65},"Zhang","15193100697","zhanglymd@126.com",{"facility":67,"status":68,"city":69,"state":70,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Sun Yat-sen Memorial 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University","Shenyang","Liaoning",{"type":56,"coordinates":99},[100,101],123.43278,41.79222,{"lat":101,"lon":100},[104],{"name":105,"role":39,"phone":106,"phoneExt":41,"email":107},"Wang","13604010738","87k016328@sina.com",{"facility":109,"status":50,"city":110,"state":111,"zip":112,"country":53,"countryCode":54,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Ying han","Xi'an","Shaanxi","710032",{"type":56,"coordinates":114},[115,116],108.92861,34.25833,{"lat":116,"lon":115},[119],{"name":44,"role":39,"phone":45,"phoneExt":41,"email":46},{"facility":121,"status":50,"city":122,"state":123,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Sichuan Provincial People's Hospital,","Chengdu","Sichuan",{"type":56,"coordinates":125},[126,127],104.06667,30.66667,{"lat":127,"lon":126},[130],{"name":131,"role":39,"phone":132,"phoneExt":41,"email":133},"Li","18981838872","18981838872@163.com",{"facility":135,"status":50,"city":136,"state":41,"zip":41,"country":53,"countryCode":54,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Tianjin Medical University General Hospital","Tianjin",{"type":56,"coordinates":138},[139,140],117.17667,39.14222,{"lat":140,"lon":139},[143],{"name":144,"role":39,"phone":145,"phoneExt":41,"email":146},"Zhou","15822531649","lzhou01@tmu.edu.cn",{"type":35,"investigatorFullName":148,"investigatorTitle":149,"investigatorAffiliation":5,"oldNameTitle":41,"oldOrganization":41},"Han Ying","Professor","100497032","phase-3-fenofibrate-combined-with-ursodeoxycholic-acid-in-subjects-with-primary-biliary-cholangitis-100497032",false,"NCT05751967","Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis","A Prospective, Multi-center, Randomized, Double-blind, Placebo-controlled Study: Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis and an Inadequate Response to Ursodeoxycholic Acid","Inclusion Criteria:\n\n* Must have provided written informed consent;\n* Age 18-75 years;\n* BMI 17-28 kg\u002Fm2\n* Male or female with a diagnosis of PBC, by at least two of the following criteria:\n\n  * History of AP above ULN for at least six months;\n  * Positive AMA titers (\\>1\u002F40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;\n  * Documented liver biopsy result consistent with PBC.\n* Incomplete response to UDCA defined by Xi'an criteria (ALP \\>2.5× ULN, AST\\>2×ULN or TBIL\\>1×ULN) after UDCA treatment for 4-6 weeks with at least one abnormal test in ALP or TBIL.\n\nExclusion Criteria:\n\n* History or presence of other concomitant liver diseases.\n* ALT\u002FAST \\> 5×ULN, TBIL \\> 3×ULN.\n* If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.\n* Allergic to fenofibrate or ursodeoxycholic acid.\n* Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.\n* Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.\n* Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).\n* Creatinine \\>1.5×ULN and creatinine clearance \\\u003C60 ml\u002Fmin.\n* Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).\n* Planned to receive an organ transplant or an organ transplant recipient.\n* Needing Liver transplantation within 1 year according to the Mayo Rick score.\n* Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator.","ALL","18 Years","75 Years",{"count":161,"type":162},150,"ESTIMATED","INTERVENTIONAL",[165],"PHASE3","Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients. However, up to 40% patients are insensitive to UDCA monotherapy, and evaluation of UDCA response at 12 months may result in long period of ineffective treatment. We aimed to develop a new criterion to reliably identify non-response patients much earlier. Recently, our team designed and validated a new early criterion for distinguishing high-risk PBC patients in a Chinese population for the first time. Our data indicated that PBC patients with ALP ≤ 2.5 × ULN, AST ≤ 2 × ULN, and TBIL ≤ 1 × ULN (Xi'an criterion) after 1 month UDCA treatment were likely to have better prognosis. It can be readily applied in the rapid identification of PBC patients who require additional therapeutic approaches. However, whether it is reasonable to apply it to the response definition of clinical research, and the guidance of PBC management and choice of second-line treatment, further research is needed.",[168],"Primary Biliary Cholangitis","2026-01-06",{"date":171,"type":172},"2026-01-08","ACTUAL",{"date":174,"type":172},"2023-02-22",{"date":176,"type":162},"2027-12-01",{"name":5,"class":6},7]