[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hepatotoxicity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hepatotoxicity":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,43,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100411252","a-long-term-study-evaluating-hepatotoxicity-associated-with-turalio-pexidartinib-treatment-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":19,"type":20},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.",[25,26],"Hepatotoxicity","Tenosynovial Giant Cell Tumor",[25,26,28,29],"Pexidartinib","TURALIO™","RECRUITING","2025-09-30",{"date":33,"type":34},"2025-10-06","ACTUAL",{"date":36,"type":34},"2021-01-07",{"date":38,"type":20},"2036-06-01",{"name":40,"class":41},"Daiichi Sankyo","INDUSTRY",8,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100477817","early-phase-1-use-of-levocarnitine-to-reduce-asparaginase-hepatotoxicity-in-patients-with-acute-lymphoblastic-leukemia-100477817","NCT05501899","Use of Levocarnitine to Reduce Asparaginase Hepatotoxicity in Patients With Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n* Patients aged 5 to \\\u003C 30 years\n* Newly diagnosed with ALL designated as NCI high-risk (HR) ALL\n* Treatment for ALL to be according to a Children's Oncology Group (COG) treatment protocol (on study or according to study)\n* Ability to take oral medications and willing to adhere to the levocarnitine regimen\n\nExclusion Criteria:\n\n* Known allergic reaction to levocarnitine or its components\n* Presence of severely compromised renal function or end-stage renal disease\n* Pregnancy or lactation\n* Warfarin therapy\n* History of seizures prior to ALL diagnosis\n* Known inborn error of metabolism","5 Years","29 Years",{"count":52,"type":20},20,"INTERVENTIONAL",[55],"EARLY_PHASE1","Acute lymphoblastic leukemia (ALL) is the most common cancer seen in pediatric oncology. The necessary chemotherapy for pediatric and adolescent and young adult (AYA) patients with ALL includes steroids, anthracyclines, asparaginase, and vincristine. One of the most hepatotoxic chemotherapy agents is asparaginase, with treatment-associated hepatotoxicity (TAH) observed in up to 60% of patients. The frequency of TAH is increased in overweight or obese patients of Latino heritage. Carnitine is a naturally-derived compound that is produced in the liver and kidneys; it is found in certain foods, such as meat, poultry, fish, and some dairy products. Endogenous carnitine transports long-chain fatty acids into the mitochondria, where they are oxidized to produce energy, and acts as scavengers of oxygen free radicals. Thus, carnitine can reduce oxidative stress and modulate inflammatory response. Levocarnitine is a supplement form of carnitine used typically in the care and management of patients with carnitine deficiency. Pediatric and AYAs with ALL will be given oral levocarnitine as a supplement during their initial phases of treatment, when the most hepatotoxic agents are administered, to determine if the incidence of liver toxicity can be reduced or eliminated.",[58,25],"Acute Lymphoblastic Leukemia","2024-08-20",{"date":61,"type":34},"2024-08-21",{"date":63,"type":34},"2023-03-03",{"date":65,"type":20},"2024-12-31",{"name":67,"class":68},"Children's Hospital of Orange County","OTHER",2,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":53,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":88,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":4},"100535392","phase-2-proof-of-concept-to-evaluate-the-efficacy-and-safety-of-prednisone-in-idiosyncratic-hepatotoxicity-100535392","NCT06251232","Proof-of-concept to Evaluate the Efficacy and Safety of Prednisone in Idiosyncratic Hepatotoxicity","Proof-of-concept Phase II Study to Evaluate the Efficacy and Safety of Prednisone in the Treatment of Idiosyncratic Hepatotoxicity and Its Mechanistic Pathways Through an Integrative Analysis: the DILI-CORT Clinical Trial","DILICORT","Inclusion Criteria:\n\n1. Female and male patients, aged ≥ 18 years.\n2. Patients who have been diagnosed with DILI by the expert committee.\n3. Patients with moderate to severe DILI (elevations of ALT or AST ≥ 5 times the Upper Limit of Normal (ULN) and serum TBL ≥ 2.5 mg\u002FdL).\n4. Patients who do not show a 15% reduction in ALT values or TBL continues to increase 5-10 days after liver damage recognition despite the withdrawal of the culprit drug.\n\nExclusion Criteria:\n\n1. No clear DILI diagnosis after an expert committee DILI assessment.\n2. DILI due to immune-checkpoint inhibitors.\n3. Presence of active infection as evidenced by positive urine or blood culture.\n4. Acute liver failure (international normalized ratio (INR) \\> 1.5 and hepatic encephalopathy).\n5. Model for End-Stage Liver Disease (MELD) ≥ 30.\n6. Known hypersensitivity to prednisone or placebo components.\n7. Pregnant or nursing mothers.\n8. Co-existing infection with hepatitis C, hepatitis B, or human immunodeficiency virus (HIV).\n9. Patients already receiving systemic steroids or other immunosuppressants.\n10. Inability to provide informed consent.\n11. Presence of clinically significant comorbid illnesses (by clinician's criteria) that might impede the completion of the study.",{"count":79,"type":20},60,[81],"PHASE2","This trial´s aim is to assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value.",[25,84,85],"Idiosyncratic Drug Effect","Prednisone",[85,87],"Idiosyncrasic hepatotoxicity","NOT_YET_RECRUITING","2024-04-04",{"date":91,"type":34},"2024-04-05",{"date":93,"type":20},"2024-05-01",{"date":95,"type":20},"2028-12-31",{"name":97,"class":68},"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud"]