[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-induced-liver-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-induced-liver-injury":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,39,72,97,126,153,178,199,227,252],{"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":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100550402","drug-induced-liver-injury-itching-study-100550402",false,"NCT06446609","Drug-induced Liver Injury: Itching Study","Understanding the Natural History and Impact of Itching (Pruritus) in Patients With Drug-induced Liver Injury (DILI)","Inclusion Criteria:\n\n* Age ≥18 (no upper age limit) and able to give informed written consent\n* Exposure to potential causal agent and diagnosed with suspected acute DILI defined as meeting one of the following analytical thresholds at enrolment (visit 1):\n\n  * alanine transaminase (ALT) ≥5 times upper limit of normal (ULN) or\n  * alkaline phosphatase ≥2 times ULN or\n  * ALT ≥3 times ULN plus total bilirubin \\>2 times ULN\n\nResults from clinical test samples collected within 36h of visit will be acceptable (as DILI is an acute event, patients are expected to recover or deteriorate quickly so enrolment aligned with diagnostic tests is necessary).\n\nExclusion Criteria:\n\n* Patients with comorbidities of eczema and urticaria associated with pruritus\n* Patients with existing diagnosis of blood-borne viral hepatitis infection (Hepatitis B\u002FC\u002FE)","ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","OBSERVATIONAL","Idiosyncratic drug-induced liver injury (DILI) is an unpredictable adverse hepatic reaction to a medication used in its therapeutic dose. DILI is the second most common cause of itching in adult Hepatology after biliary obstruction. In particular cholestatic or mixed pattern types of DILI (in which bile flow from the liver is impaired) are associated with long-lasting effects as well as reduced quality of life. There is therefore an urgent need to determine the incidence and natural history of itching in DILI and establish a network of centres that will form a basis for a clinical trial to investigate a novel intervention to treat these.",[24,25],"Drug Induced Liver Injury","Pruritus","RECRUITING","2026-04-24",{"date":29,"type":30},"2026-04-30","ACTUAL",{"date":32,"type":30},"2025-06-30",{"date":34,"type":20},"2028-05",{"name":36,"class":37},"University of Nottingham","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":50,"conditions":51,"keywords":52,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100084713","drug-induced-liver-injury-dili-network-retrospective-100084713","NCT00360646","Drug-Induced Liver Injury (DILI) Network Retrospective","Idiosyncratic Liver Injury Associated With Drugs (ILIAD): A Retrospective Study","ILIAD","Inclusion Criteria:\n\nScreening Criteria\n\nTo be included in the ILIAD registry, the following criteria must be satisfied:\n\n* The treating gastroenterologist \u002F hepatologist or health care professional must believe that the subject suffered drug-induced liver injury;\n* The subject must be alive and the date of onset of the qualifying DILI episode must have occurred on or after January 1, 1994;\n* Evidence of injury that is known or suspected to be related to consumption of a drug or HDS\u002FCAM product\n* The subject is taking only one of these drugs or HDS agent(s) in the period leading up to the onset of the qualifying DILI episode;\n* Have clinically important DILI defined in terms of serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (Alk Phos).\n* Sufficient documentation of the event for the Causality Committee to make a determination.\n\nExclusion Criteria:\n\nSubjects will be excluded according to the following criteria:\n\n* are not willing to have medical information and blood samples taken;\n* are unable to adequately give informed consent to participate in the study including the blood draw for the genetic component;\n* age \\\u003C 2 years old at the time of study enrollment (due to blood volume requirements).\n* Have a competing cause of liver injury such as hepatic ischemia that the investigator felt to be the primary reason for the observed liver injury. Known, pre-existing autoimmune hepatitis; primary biliary cirrhosis, primary sclerosing cholangitis, or other chronic biliary tract disease. Subjects are excluded due to acetaminophen hepatoxicity or liver transplant or allogeneic bone marrow transplant prior to development of drug-CAM induced liver injury.","2 Years",{"count":49,"type":20},400,"The purpose of this study is to establish retrospectively a nationwide registry of patients who have suffered drug-induced liver injury (DILI), and to collect, immortalize, and store serum, DNA, and lymphocytes from these patients. ILIAD will serve as a resource for subsequent mechanistic investigations into the basis of severe idiosyncratic DILI. The primary goal of the ILIAD protocol is to create: (a) a clinical database consisting of individuals who have experienced severe DILI and the relevant clinical data concerning the episode of DILI; and, (b) to create a bank of biological specimens obtained from these individuals. These biological specimens will be DNA, plasma, and immortalized lymphocytes. Immortalized lymphocytes will provide unlimited amounts of genomic DNA for study as well as living immune cells for phenotyping studies.\n\nA secondary goal of the ILIAD protocol is to maintain a registry of cases in the ILIAD database so that they may be recontacted in the future. It is expected that this will facilitate additional studies exploring the mechanisms of DILI.",[24],[53,54,55,56,57,58,59,60,61],"LIVER DIS","CHEM IND","Drugs","Drug induced liver injury","phenotype","cholestatic liver injury","hepatocellular liver injury","mixed liver injury","genotype","2026-04-06",{"date":64,"type":30},"2026-04-08",{"date":66,"type":30},"2004-09",{"date":68,"type":20},"2028-07-31",{"name":70,"class":37},"Duke University",6,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100629608","a-real-world-study-of-polyene-phosphatidylcholine-injection-for-the-prevention-and-treatment-of-dili-in-patients-with-malignant-hematological-diseases-100629608","NCT07476885","A Real World Study of Polyene Phosphatidylcholine Injection for the Prevention and Treatment of DILI in Patients With Malignant Hematological Diseases","PPC-HM-DILI","Inclusion Criteria:\n\n* Over 18 years old, gender not limited;\n* Confirmed by histology or cytology as malignant hematological diseases (including but not limited to acute myeloid leukemia, acute lymphoblastic leukemia, non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma);\n* Patients who have received at least one cycle of chemotherapy regimens with a clear risk of hepatotoxicity;\n* Receive treatment with polyene phosphatidylcholine injection or prevent liver injury;\n* Liver injury treatment drugs are used in combination, and drugs containing the following are used in combination with polyene phosphatidylcholine injection. The combined use of drugs includes one or both of magnesium isoglycyrrhizinate injection, glutathione injection, adenosylmethionine succinate injection\u002Ftablet, ursodeoxycholic acid oral preparation, and bicyclol alcohol tablets. In addition, those who have not used other liver-protecting drugs;\n* Those who have at least one record of liver function test within 7 days before and after the application of liver injury treatment drugs.\n\nExclusion Criteria:\n\n* Patients with significantly missing main research data, including age, gender, liver function indicators (ALT\u002FAST\u002FTBIL) before and after treatment, and important information related to disease diagnosis and treatment;\n* For active viral hepatitis, autoimmune liver disease, alcoholic or non-alcoholic fatty liver disease, etc., identify other major causes of liver damage;\n* Those who have used drugs with therapeutic effects on liver damage one week before treatment; Other researchers determine those who affect the evaluation of therapeutic effects.",{"count":80,"type":20},1000,"This is a retrospective, multicenter real-world observational study. Its main goal is to find out if Polyene Phosphatidylcholine Injection works to treat drug-induced liver injury (DILI) in adults with hematologic malignancies, and to check if the drug is safe.\n\nIt also aims to answer these key questions:\n\nDoes Polyene Phosphatidylcholine Injection help prevent DILI in people with hematologic malignancies? How effective and safe are different combinations of Polyene Phosphatidylcholine Injection with other liver-protective drugs for DILI? Which DILI treatment plan offers better value for money?\n\nWho can take part?\n\nParticipants must meet all these criteria:\n\n18 years or older (no gender restriction) Diagnosed with a hematologic malignancy (such as leukemia, lymphoma, or multiple myeloma) Received at least one cycle of chemotherapy that may harm the liver Used Polyene Phosphatidylcholine Injection to treat or prevent DILI (alone or with one\u002Ftwo specific liver-protective drugs: Magnesium Isoglycyrrhizinate Injection, Glutathione Injection, Ademetionine 1,4-Butanedisulfonate Injection\u002FTablets, Ursodeoxycholic Acid Oral Formulation, or Bicyclol Tablets) Had liver function tests within 7 days before starting treatment and at least once after starting treatment\n\nWhat will the study involve?\n\nResearchers will look back at medical records of eligible participants treated on or before November 30, 2025. They will collect and analyze:\n\nParticipants' basic information (age, gender) and disease details Details about Polyene Phosphatidylcholine Injection use (dose, frequency, duration) Liver function test results (including alanine aminotransferase \\[ALT, a liver enzyme that rises when the liver is injured\\], aspartate aminotransferase \\[AST\\], total bilirubin \\[TBIL\\], and other related indicators) at different time points (3 days, 7 days, 14 days, 21 days, 30 days, 60 days) after starting treatment Any unwanted health issues (adverse events, AEs) during treatment and how they were managed Costs related to treatment (drug fees, test fees, AE management fees)\n\nWhat are the key things researchers will measure? Main measure: How well ALT levels improve 7 days after starting Polyene Phosphatidylcholine Injection (defined as ALT dropping by more than 50% or returning to normal)\n\nSecondary measures:\n\nImprovement in liver function indicators at other time points (3 days, 14 days, 21 days, 30 days, 60 days) How well the drug prevents DILI (how often DILI occurs and how severe it is) Differences in effectiveness and safety between different drug combinations Which treatment plan is more cost-effective",[83],"Drug-Induced Liver Injury",[85,86],"PPC","DILI","NOT_YET_RECRUITING","2026-03-12",{"date":90,"type":30},"2026-03-17",{"date":92,"type":20},"2026-03-31",{"date":94,"type":20},"2027-01-31",{"name":96,"class":37},"Institute of Hematology & Blood Diseases Hospital, China",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":4,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":104,"enrollmentInfo":105,"targetDuration":4,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":112,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":38},"100586998","glucocorticoids-for-acute-drug-induced-liver-injury-with-hyperbilirubinemia-100586998","NCT06922669","Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia","Efficacy and Safety of Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* A definite diagnosis of acute DILI;\n* 5×ULN ≤ TBIL level at baseline ≤ 20×ULN;\n* Age 18-80 years old;\n* Sign the informed consent form.\n\nExclusion Criteria:\n\n* Other causes of liver injury, including viral hepatitis, cytomegalovirus infection, Epstein-Barr virus infection, Herpes virus infection, autoimmune liver disease, alcoholic liver disease, hypoxic\u002Fischemic liver disease, Budd-Chiari syndrome, biliary tract disease, Wilson's disease, hemochromatosis, and α1-antitrypsin deficiency;\n* Immune checkpoint inhibitors or gynura segetum induced DILI;\n* Absolute contraindications to glucocorticoids, such as systemic mold infections or allergies;\n* A history of glucocorticoid therapy within 3 months before enrollment;\n* A history of diseases requiring glucocorticoid maintenance therapy, such as rheumatoid arthritis, systemic lupus erythematosus, systemic dermatomyositis, etc;\n* A history of liver transplantation;\n* Received artificial liver therapy before enrollment;\n* Malignant tumor of the liver, bile duct, pancreas or liver metastasis\n* Acute liver failure;\n* Renal dysfunction, creatinine Cr≥133μmol\u002FL;\n* Neutrophil count \\\u003C1,000,000,000\u002FL;\n* Active tuberculosis;\n* Severe cardiopulmonary diseases;\n* Recent surgery or trauma;\n* Mental illness;\n* Pregnancy or lactation;\n* Participated in other clinical studies within 3 months before enrollment;\n* Other conditions judged by the clinician to be inappropriate for study participation.","80 Years",{"count":106,"type":20},232,"INTERVENTIONAL",[109],"NA","Drug-induced liver injury (DILI) can lead to potentially fatal complications, such as acute liver failure and even death. In clinical practice, glucocorticoids have been considered in some cases of DILI, especially patients with hyperbilirubinemia. However, the available evidence remains controversial and its quality is also very limited. Herein, a multicenter randomized controlled trial (RCT) has been designed to explore the efficacy and safety of glucocorticoids in patients with acute DILI and hyperbilirubinemia.",[24],[56,113,114,115,116],"liver failure","glucocorticoids","clinical trial","Hyperbilirubinemia","2025-12-17",{"date":119,"type":30},"2025-12-18",{"date":121,"type":30},"2025-06-24",{"date":123,"type":20},"2027-09-30",{"name":125,"class":37},"General Hospital of Shenyang Military Region",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":47,"studyType":21,"phases":4,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":152},"100443890","a-prognostic-model-for-drug-induced-liver-injury-in-china-100443890","NCT05060289","A Prognostic Model for Drug-induced Liver Injury in China","A Prognostic Model for Drug-induced Liver Injury in China : A Multi-center, Prospective Cohort Study","DILI-PM","Inclusion Criteria:\n\n1. RUCAM ≥6 and met one of the following biochemical conditions: (1) ALT≥5 ULN, (2) or ALP ≥2 ULN, (3) or ALT≥3 ULN and TBil≥2 ULN.\n2. RUCAM between 3-5, five experienced hepatologists in leading site evaluate and vote the diagnosis of DILI, the case would be enrolled if only ≥4 out of 5 hepatologists agree with the diagnosis.\n3. Onset to enrollment ≤3 months.\n\nExclusion Criteria:\n\n1. Hepatotropic viral infection: hepatitis A, B, C, D and E.\n2. Non-hepatotropic viral infection: cytomegalovirus (CMV) and Epstein-Barr virus (EBV), etc.\n3. Hypoxic ischemic hepatitis and congestive liver disease.\n4. Alcohol consumption: male \\>40g\u002Fd, female \\>20g\u002Fd, and ≥5 years.\n5. Biliary obstruction, primary biliary cholangitis; primary sclerosing cholangitis.\n6. Autoimmune hepatitis: International Autoimmune Hepatitis Group (IAHG) simplified score ≥6 or complicated score ≥10, or differentiation from autoimmune hepatitis is impossible during enrollment.\n7. Parasitic infection.\n8. Sepsis.\n9. Previous liver transplantation or bone marrow transplantation.\n10. Pregnancy or lactation.\n11. Genetic and metabolic liver diseases.",{"count":135,"type":20},3000,"A prospective, multi-center, non-interventional cohort study is going to conduct to explore the clinical characteristics, culprit drug(s) or herb(s), outcomes and risk factors of Drug-induced liver injury (DILI) in China and screen novel serum markers.\n\nA prognostic model incorporating with the novel serum marker(s) for DILI would be established and validated to imporve the prognosis of patients in China .",[138],"Drug-induced Liver Injury",[140,141,142],"prognostic model(s)","biomarker(s)","endpoint event(s)","2025-09-17",{"date":145,"type":30},"2025-09-22",{"date":147,"type":30},"2022-05-25",{"date":149,"type":20},"2028-12-31",{"name":151,"class":37},"Beijing Friendship Hospital",13,{"id":154,"slug":155,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":159,"maxAge":104,"enrollmentInfo":160,"targetDuration":4,"studyType":107,"phases":162,"briefSummary":164,"conditions":165,"keywords":167,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":4},"100597407","phase-1-comparison-of-the-outcome-of-treatment-with-silymarin-or-n-aceylcysteine-in-patients-taking-anti-tuberculous-drugs-for-tuberculosis-at-a-tertiary-care-hospital--karachi-100597407","NCT07058090","Comparison of the Outcome of Treatment With Silymarin or N-Aceylcysteine in Patients Taking Anti-Tuberculous Drugs for Tuberculosis at a Tertiary Care Hospital , Karachi","Inclusion Criteria:\n\n* Patients presenting with tuberculosis and previously not on any anti-tuberculous drugs, between 40-80 years of age\n* either gender.\n\nExclusion Criteria:\n\n* History of malignancy.\n* Patients with history of seropositive, seronegative, connective tissue disorder or vasculitis, congestive cardiac failure.\n* Patients with history of alcohol use.\n* Discontinuation of drug due to other adverse effects except hepatotoxicity.\n* Inadequate date of laboratory testing at baseline or 2 to 4 weeks after treatment initiation.\n* Cases with human immunodeficiency virus (HIV) co-infection, viral hepatitis, or suspected mal absorption (e.g., gastrointestinal disease or diarrhea).\n* Chronic liver disease, COPD, asthma, myocardial infarction, chronic kidney disease and stroke.","40 Years",{"count":161,"type":20},410,[163],"PHASE1","OBJECTIVE : To compare the outcome of treatment with silymarin or N-acetyl cysteine in patients taking anti-tuberculous drugs for tuberculosis at Tertiary Care Hospital, Karachi.\n\nSAMPLE SELECTION : Patients presenting with tuberculosis previously not on anti-tuberculous drugs, between 40-80 years of age, both genders will be included .Patients with history of alcohol use,Discontinuation of drug due to other adverse effects except hepatotoxicity ,Inadequate date of laboratory testing at baseline or 2 to 4 weeks after treatment initiation, Cases with human immunodeficiency virus (HIV) co-infection, viral hepatitis, or suspected mal absorption (e.g., gastrointestinal disease or diarrhea) ,Chronic liver disease, COPD, asthma, myocardial infarction, chronic kidney disease and stroke will be excluded",[24,166],"Tuberculosis (TB)",[168],"prevention of Antituberculous drugs induced liver injury","2025-07-04",{"date":171,"type":30},"2025-07-10",{"date":173,"type":20},"2025-07",{"date":175,"type":20},"2026-05",{"name":177,"class":37},"Liaquat National Hospital & Medical College",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":38},"100282812","a-prospective-cohort-study-on-drug-induced-liver-injury-in-chinadili-p-100282812","NCT02961413","A Prospective Cohort Study on Drug-induced Liver Injury in China（DILI-P）","A Multi-center, Prospective, Non-interventional Cohort Study on Drug Induced Liver Injury in Mainland China","DILI-P","Inclusion Criteria:\n\n* Diagnosis of DILI patients with various types and severity according to the 2015 version of the Chinese DILI treatment guidelines\n* RUCAM ≥6, or RUCAM between 3-5 is required by the three experts determined that the drug-induced liver injury\n* patient can provide informed consent form\n\nExclusion Criteria:\n\n* non-drug-induced liver injury",{"count":187,"type":20},10000,"This is a multi-center, prospective, non-interventional cohort study .\n\nIts primary objectives are:\n\n1. assess DILI patients' clinical characteristics, disease progression and influencing factors in clinical practice;\n2. learn about suspected drug caused DILI,rechallenging, liver biochemical abnormalities mode, etc.",[138],"2025-04-30",{"date":192,"type":30},"2025-05-04",{"date":194,"type":4},"2016-04",{"date":196,"type":20},"2030-12",{"name":198,"class":37},"Drug Induced Liver Disease Study Group",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":11,"sex":16,"minAge":207,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":210,"conditions":211,"keywords":215,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":38},"100436519","screening-of-susceptibility-genes-for-apap-induced-drug-induced-liver-injury-in-chinese-population-a-case-control-study-100436519","NCT04964310","Screening of Susceptibility Genes for APAP Induced Drug Induced LIver Injury in ChiNese Population: a Case-control Study","Pharmacogenomics of APAP Induced DILI in Chinese Population.","PAIN","Inclusion criteria：\n\n* A clear history of acetaminophen (or acetaminophen-containing drugs) ingestion.\n* Plasma and\u002For urine testing for acetaminophen components if history of ingestion is unclear.\n* Monitoring of Alanine aminotransferase (ALT) or Aspartate Aminotransferase (AST) ≥ 1000 IU\u002FL at any time after APAP administration and Roussel Uclaf Causality Assessment Method(RUCAM) score \\> 6\n* Age ≥ 14 years old\n* The subject or guardian agrees to participate in this project and signs an informed consent form.\n\nExclusion criteria：\n\n* The use of drugs for which frequency of adverse reactions to liver damage is defined as \"common or very common\" (≥1%) in the instructions.\n* Concurrent use of herbs that are clearly susceptible to liver damage (see list of definitions in the Annex).\n* Have a known definite cause of liver damage: active viral hepatitis; alcoholic liver disease; autoimmune liver disease; primary or secondary liver tumors; and other underlying liver disease that has affected liver function.\n* Those who fail to provide complete general information and clinical information.\n* Subjects or guardians who do not agree to see this project do not sign the informed consent form.","14 Years",{"count":209,"type":20},339,"Acetaminophen (APAP) is the most commonly used NSAIDS in clinic, and it is also a common cause of drug-induced liver injury (DILI). In 2012, the proportion of DILI caused by APAP in the United States was 51%, while in Asia, it was only 7.10%. Previously, a small cohort study in the United States screened for some of the susceptibility genes for DILI due to APAP by the Genome wide association study (GWAS) method. However, the genetic susceptibility loci based on the US cohort were not applicable to the Chinese population. Therefore, we make a study design include Chinese population who ingested APAP and divided them into case group and control group according to the occurrence of DILI. We hope to be able to find the root of differences at the genetic level and explore new pathogenic mechanisms.",[212,83,213,214],"Acetaminophen","Pharmacogenetics","China",[212,83,213,214,216,217],"Case-Control Studies","candidate gene","2025-02-24",{"date":220,"type":30},"2025-02-26",{"date":222,"type":30},"2020-08-31",{"date":224,"type":20},"2026-12-31",{"name":226,"class":37},"The First Affiliated Hospital with Nanjing Medical University",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":234,"enrollmentInfo":235,"targetDuration":4,"studyType":107,"phases":237,"briefSummary":240,"conditions":241,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":38},"100577339","phase-2-efficacy-of-plasmapheresis-in-patients-of-drug-induced-liver-injury-dili-with-underlying-chronic-liver-disease-100577339","NCT06797011","Efficacy of Plasmapheresis in Patients of Drug-Induced Liver Injury (DILI) With Underlying Chronic Liver Disease","Efficacy of Plasmapheresis in Patients of Drug-Induced Liver Injury (DILI) With Underlying Chronic Liver Disease: An Open Labelled RCT","Inclusion Criteria:\n\n1. Adults aged 18-75 years with previously known or unknown underlying CLD.\n2. Diagnosis of DILI based causality of assessment by RECAM.\n3. Severe DILI with bilirubin \\> 12mg\u002Fdl or INR\\>2, S.Bili \\>5 mg\u002Fdl.\n4. Consent to participate in the study (based on biopsy\u002Fimaging\u002For clinical criteria).\n\nExclusion Criteria:\n\n1. Active infection\n2. Contraindications to plasmapheresis (e.g., severe coagulopathy, hemodynamic instability, patients with sepsis, shock, poor P\u002FF ratio).\n3. Pregnant or breastfeeding women.\n4. HCC or any malignancy\n5. UGI bleed, uncontrolled HE\n6. Option LTx being considered\n7. S. Creatinine \\> 2mg\u002FdL\n8. DILI ALF\n9. Alcoholic Hepatitis","75 Years",{"count":236,"type":20},96,[238,239],"PHASE2","PHASE3","DILI is an underdiagnosed and under appreciated causal or contributing factor to liver injury. DILI can mimics features of the entire spectrum of acute and chronic liver disease.\n\nAsia-Pacifc region is characterized by two unique features; the high prevalence of tuberculosis (TB) in the population and the ubiquitous use of traditional and complimentary medicines.Current definition of Hy's law presents significant difficulties when dealing with patients with preexisting CLD in clinical trials. Hallmark of the hepatic manifestation in these patients is hyperbilirubinemia and coagulopathy rather than ALT elevation.",[24,242],"Chronic Liver Disease","2025-01-27",{"date":245,"type":30},"2025-01-28",{"date":247,"type":20},"2025-01-25",{"date":249,"type":20},"2026-01-31",{"name":251,"class":37},"Institute of Liver and Biliary Sciences, India",{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":258,"enrollmentInfo":259,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":38},"100575340","prospective-comparative-validation-study-of-rucam-and-recam-100575340","NCT06771011","Prospective Comparative Validation Study of RUCAM and RECAM","Inclusion Criteria:\n\n1. Older than 18 years old\n2. Acute liver injury within 3 months of onset and biochemical meeting one of the following criteria: ALT≥5 ULN; ALP≥2 ULN; ALT≥3 ULN and TBil≥2 ULN\n3. The patients had a clear history of medication: the time from medication to onset, the time from drug withdrawal to onset, the time of the first laboratory test and the peak laboratory test, the reason for taking medication, the name of the drug, the dose of the drug, and the frequency. If the causative drug includes traditional Chinese medicine, the specific name of all the components or patent Chinese medicine in the prescription, a single drug or single component, or the main ingredient in the prescription causing liver injury should be provided\n4. All the key data for RUCAM and RECAM can accurately be contained.\n5. Follow-up outcomes confirmed that the cause of the acute liver injury was any of the following liver diseases: Drug-induced liver injury, acute viral hepatitis (including acute viral hepatitis A, acute viral hepatitis B or acute exacerbation of chronic hepatitis B, acute viral hepatitis E), alcoholic liver disease, autoimmune hepatitis, biliary calculi, biliary obstruction, hypoxic-ischemic hepatitis, congestive liver disease and other liver diseases\n\nExclusion Criteria:\n\n1. The incubation period cannot be accurately calculated: the dates of starting medication, stopping medication, and onset of illness cannot be accurately described, resulting in the inability to calculate the incubation period\n2. Can not be clear about the pathogenic drug: the pathogenic drug is only described as \"traditional Chinese medicine, cold medicine, antipyretic medicine\", but cannot be clear about what kind of medicine\n3. Missing biochemical data, resulting in inability to assess the time of 50% decrease in liver biochemistry (ALT or ALP, TBIL) from the peak after drug withdrawal\n4. The cause of the patient's acute liver injury could not be determined\n5. Acetaminophen liver injury\n6. Toxic liver disease, such as mushroom poisoning caused liver damage, chemical poisons (such as paint, etc.) liver damage\n7. Previous liver transplantation and bone marrow transplantation\n8. Pregnancy or lactation","85 Years",{"count":260,"type":20},407,"A total of 407 hospitalized patients with acute liver injury in Beijing Friendship Hospital Affiliated to Capital Medical University were enrolled. The clinical information, biochemical examination, imageological examination (ultrasound, CT, MRI) and liver biopsy pathology of patients with acute liver injury will be collected. The diagnostic efficacy of RECAM and RUCAM in the diagnosis of DILI will be compared, and the consistency of different clinicians in the diagnosis of DILI using RECAM and RUCAM scores will also be compared.",[24],"2025-01-07",{"date":265,"type":30},"2025-01-13",{"date":267,"type":30},"2023-05-01",{"date":269,"type":20},"2026-05-01",{"name":151,"class":37}]