[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100411252":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":25,"studyPopulation":26,"armGroups":27,"interventions":33,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":138,"collaborators":19,"id":140,"slug":19,"hasResults":141,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":19,"eligibilityCriteria":145,"healthyVolunteers":141,"sex":146,"minAge":147,"maxAge":19,"enrollmentInfo":148,"targetDuration":151,"studyType":152,"phases":19,"briefSummary":153,"conditions":154,"keywords":157,"overallStatus":52,"whyStopped":19,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Daiichi Sankyo","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":19},[9],{"measure":10,"description":11,"timeFrame":12},"Frequency of Hepatic Failure After Discontinuation of TURALIO™ (pexidartinib)","Hepatic failure is defined as severe liver injury with encephalopathy and impaired synthetic function (INR \\>= 1.5) as well as liver transplant and hepatic-related death.","Baseline up to 10 years",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Number of Participants With Liver Test Abnormalities","Liver test abnormalities were defined as the following: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>3 × upper limit of normal (ULN) with concurrent total bilirubin (TBIL) \\>2 × ULN; Isolated TBIL \\>2 × ULN (excluding patients with Gilbert's syndrome); Isolated AST or ALT \\>10 × ULN; Alkaline phosphatase (ALP) \\>2 x ULN with gamma-glutamyl transferase (GGT) \\>2 x ULN.",{"measure":18,"description":19,"timeFrame":12},"Number of Participants With A Liver Transplant",null,{"measure":21,"description":19,"timeFrame":12},"Number of Participants Experiencing Death",{"allocation":19,"interventionModel":19,"interventionModelDescription":19,"primaryPurpose":19,"observationalModel":23,"timePerspective":24,"maskingInfo":19},"COHORT","PROSPECTIVE","This FDA post-marketing requirement study will evaluate the long-term risk of hepatic failure with TURALIO™ (pexidartinib) and the mechanism of liver injury based upon liver biopsy information among patients who received or are receiving TURALIO™ (pexidartinib) for symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery, and who experience hepatotoxicity. An optional liver biopsy will be collected from enrolled patients for central laboratory analysis of macrophage and immune cell profiles to investigate possible mechanisms of the hepatotoxicity. Additionally, 4 blood samples will be collected to evaluate liver function, other relevant safety tests, peripheral immune cells, and for pharmacogenomic testing. Enrolled patients will be followed at least yearly for 10 years to assess long-term risk of hepatic failure.","Adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery, who experience moderate or severe hepatotoxicity due to TURALIO™ (pexidartinib).",[28],{"label":29,"type":19,"description":30,"interventionNames":31},"Symptomatic TGCT Participants","Adult patients with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery, and who experience moderate or severe hepatotoxicity due to use of TURALIO™ (pexidartinib).",[32],"Drug: TURALIO™",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":19},"DRUG","TURALIO™","This is a non-interventional, observational study to evaluate long-term risk of hepatic failure associated with TURALIO™ (pexidartinib) treatment. No study medication will be provided to the participants.",[29],[40],{"name":41,"affiliation":5,"role":42},"Global Clinical Leader","STUDY_DIRECTOR",[44],{"name":45,"role":46,"phone":47,"phoneExt":19,"email":48},"Daiichi Sankyo Contact for Clinical Trial Information","CONTACT","908-992-6400","CTRinfo@dsi.com",[50,67,75,83,93,105,114,126],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Kamalesh K Sankhala MD INC","RECRUITING","Santa Monica","California","90403","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-118.49138,34.01949,{"lat":62,"lon":61},[65],{"name":66,"role":46,"phone":19,"phoneExt":19,"email":19},"Principal Investigator",{"facility":68,"status":69,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Sarcoma Oncology Research Center LLC","NOT_YET_RECRUITING",{"type":59,"coordinates":71},[61,62],{"lat":62,"lon":61},[74],{"name":66,"role":46,"phone":19,"phoneExt":19,"email":19},{"facility":76,"status":52,"city":53,"state":54,"zip":77,"country":56,"countryCode":57,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"UCLA Hematology and Oncology","90404",{"type":59,"coordinates":79},[61,62],{"lat":62,"lon":61},[82],{"name":66,"role":46,"phone":19,"phoneExt":19,"email":19},{"facility":84,"status":85,"city":86,"state":54,"zip":87,"country":56,"countryCode":57,"cosmosGeoPoint":88,"geoPoint":92,"contacts":19},"The Oncology Institute of Hope and Innovation","WITHDRAWN","Whittier","90602",{"type":59,"coordinates":89},[90,91],-118.03284,33.97918,{"lat":91,"lon":90},{"facility":94,"status":52,"city":95,"state":96,"zip":97,"country":56,"countryCode":57,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Dana-Farber Cancer Institute","Boston","Massachusetts","02215",{"type":59,"coordinates":99},[100,101],-71.05977,42.35843,{"lat":101,"lon":100},[104],{"name":66,"role":46,"phone":19,"phoneExt":19,"email":19},{"facility":106,"status":85,"city":107,"state":107,"zip":108,"country":56,"countryCode":57,"cosmosGeoPoint":109,"geoPoint":113,"contacts":19},"Montefiore Medical Center","New York","10467",{"type":59,"coordinates":110},[111,112],-74.00597,40.71427,{"lat":112,"lon":111},{"facility":115,"status":52,"city":116,"state":117,"zip":118,"country":56,"countryCode":57,"cosmosGeoPoint":119,"geoPoint":123,"contacts":124},"OSU - James Comprehensive Cancer Center","Columbus","Ohio","43210",{"type":59,"coordinates":120},[121,122],-82.99879,39.96118,{"lat":122,"lon":121},[125],{"name":66,"role":46,"phone":19,"phoneExt":19,"email":19},{"facility":127,"status":69,"city":128,"state":129,"zip":130,"country":56,"countryCode":57,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Kelsey Seybold Clinic - Pearland","Houston","Texas","77014",{"type":59,"coordinates":132},[133,134],-95.36327,29.76328,{"lat":134,"lon":133},[137],{"name":66,"role":46,"phone":19,"phoneExt":19,"email":19},{"type":139,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100411252",false,"NCT04635111","A Long-term Study Evaluating Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment","A Long-term Study to Further Evaluate the Risk of Hepatotoxicity Associated With TURALIO™ (Pexidartinib) Treatment","Inclusion Criteria:\n\n* Adult participants with symptomatic TGCT associated with severe morbidity or functional limitations and not amenable to improvement with surgery\n* Age ≥18 years old\n* Emergence of at least one of the following liver test abnormalities due to TURALIO™ (pexidartinib) exposure:\n\n  * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>3 × upper limit of normal (ULN) with concurrent total bilirubin (TBIL) \\>2 × ULN\n  * Isolated TBIL \\>2 × ULN (excluding patients with Gilbert's syndrome)\n  * Isolated AST or ALT \\>10 × ULN\n  * Alkaline phosphatase (ALP) \\>2 x ULN with gamma-glutamyl transferase (GGT) \\>2 x ULN\n* Consent to study procedures, long-term safety follow-up, and use of data from the TURALIO™ (pexidartinib) Risk Evaluation and Mitigation Strategy (REMS) program\n\nExclusion Criteria:\n\n* Not applicable","ALL","18 Years",{"count":149,"type":150},30,"ESTIMATED","10 Years","OBSERVATIONAL","A study to evaluate the long-term risk of hepatic failure with TURALIO™ (pexidartinib) and the mechanism of liver injury based upon optional liver biopsy information among patients who received or are receiving TURALIO™ (pexidartinib) and experience hepatotoxicity.",[155,156],"Hepatotoxicity","Tenosynovial Giant Cell Tumor",[155,156,158,36],"Pexidartinib","2025-09-30",{"date":161,"type":162},"2025-10-06","ACTUAL",{"date":164,"type":162},"2021-01-07",{"date":166,"type":150},"2036-06-01",{"name":5,"class":6},8]