[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-transplant-complications\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-transplant-complications":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,43,68,91,114,151,175,198,238,263,289,313,335,362,382,413,436,457,483,507,531,559,583,603,630],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100616419","phase-2-seladelpar-in-adult-liver-transplant-recipients-with-ischemic-cholangiopathy-selic-100616419",false,"NCT07305363","Seladelpar in Adult Liver Transplant Recipients With Ischemic Cholangiopathy (SELIC).","The SELIC Trial Seladelpar for the Treatment of Ischemic Cholangiopathy: An Open-Label, Single-Arm, Investigator-Initiated Study","SELIC","Inclusion Criteria:\n\n1. Adult, age ≥ 18 and \\\u003C 80 years\n2. Diagnosis of ischemic cholangiopathy defined as non-anastomotic biliary strictures confirmed by imaging (ERCP, MRI, percutaneous cholangiogram)\n3. Cholestasis noted by elevated alkaline phosphatase (ALP) and gamma glutamyl transferase (GGT)\n4. Imaging and clinical findings present at least 4 weeks after but within 12 months of liver transplantation\n5. No recent hospitalization within 2 weeks before enrollment to ensure clinical stability\n\nExclusion Criteria:\n\n1. Decompensated liver disease, including but not limited to ascites requiring paracentesis, hepatic encephalopathy, or variceal bleeding.\n2. Pregnancy or breastfeeding.\n3. Current or recent (within 30 days) use of other investigational agents or fenofibrate.\n4. Current or recent (within 30 days) use of cyclosporine\n5. Known hypersensitivity or contraindication to seladelpar or its excipients.\n6. Severe concomitant illness (renal, cardiac, or other systemic condition) that, in the investigator's judgment, would interfere with study participation or interpretation of results.\n7. ALT \\> 150 IU\u002FL.\n8. AST \\> 150 IU\u002FL.\n9. Total bilirubin \\> 5 mg\u002FdL at screening","ALL","18 Years","79 Years",{"count":22,"type":23},10,"ESTIMATED","INTERVENTIONAL",[26],"PHASE2","A prospective, open-label, single-arm, investigator-initiated study (SELIC) to evaluate the efficacy and safety of seladelpar in adult liver transplant recipients with Ischemic cholangiopathy (IC).",[29,30],"Liver Transplant; Complications","Ischemic Cholangiopathy","NOT_YET_RECRUITING","2026-04-03",{"date":34,"type":35},"2026-04-09","ACTUAL",{"date":37,"type":23},"2026-05",{"date":39,"type":23},"2027-12",{"name":41,"class":42},"University of California, San Diego","OTHER",{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":24,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100566029","phase-1-adipose-derived-mesenchymal-stem-cell-for-preventing-biliary-complications-100566029","NCT06649864","Adipose-Derived Mesenchymal Stem Cell for Preventing Biliary Complications","A Phase I Study of Autologous Adipose-derived Mesenchymal Stromal Cells in Preventing Biliary Complications After Living Donor Liver Transplant","Inclusion Criteria\n\n* Listed for liver transplantation\n* Non-pediatric patients with a planned LDLT\n* Ability to communicate with investigative staff\n* Competence to give written informed consent\n* Ability to comply with the entire study procedure\n* All sexes and genders will be eligible for the study\n\nExclusion Criteria\n\n* Planned deceased donor liver transplantation\n* Uncontrolled \u002F unresolved local or systemic infection\n* Body mass index \\> 40\n* Planned pancreaticoduodenectomy or sleeve gastrectomy\n* Anticipation of 3 biliary anastomoses (we will include those anticipated to have 1 or 2 biliary anastomoses as detailed below)\n* Pregnancy or breastfeeding\n* Non-liver cancers (we will include certain patients with primary liver cancer as detailed below)\n* Treatment with any investigational drug \u002F device within 60 days prior to study entry\n* Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of AMSCs\n* Patients who are employees or relatives of the investigator","65 Years",{"count":52,"type":23},20,[54],"PHASE1","The purpose of this study is to assess the safety of autologous Adipose-Derived Mesenchymal Stem Cell for use in End-Stage Liver Disease patients undergoing the creation of a duct-to-duct anastomosis during Living Donor Liver Transplantation.",[29,57],"Liver Diseases","2026-03-31",{"date":60,"type":35},"2026-04-06",{"date":62,"type":23},"2027-02",{"date":64,"type":23},"2028-06",{"name":66,"class":42},"Mayo Clinic",1,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100535867","perioperative-hemostasis-management-in-liver-transplantation-100535867","NCT06257407","Perioperative Hemostasis Management in Liver Transplantation","HEMOTRANSPLANT","Inclusion Criteria:\n\n* Patients aged 18 or over\n* Liver transplant patient\n\nExclusion Criteria:\n\n* Multi-organ transplantation\n* Protected populations: under guardianship or curatorship\n* Patients not affiliated to a social security scheme",{"count":76,"type":23},1200,"OBSERVATIONAL","Liver transplantation (LT) is a surgery with risk of bleeding. Several risk factors have been identified: complex dissection, portal hypertension, history of ascites fluid infections, history of surgical procedures, pre-existing complex hemostatic disorders and those acquired during the procedure. Diffuse bleeding can occur at any time during the 3 phases of surgery: dissection, anhepatic and neohepatic. However, intraoperative bleeding and transfusion requirements remain difficult to predict. Current predictive models are based in particular on preoperative characteristics and do not take into account the course and different phases of the operation.\n\nThe need for transfusions has largely decreased over the last 20 years, and currently around 20-25% of patients are transfused (transfusion of at least 1 blood product during LT). However, massive transfusion is necessary in 10% of LT. The European Society of Anaesthesiology (ESA) has issued recommendations on the management of severe bleeding during surgery. However, these recommendations are not specific to LT. Moreover, transfusion strategies vary widely from one center to another. The implementation of protocols within teams dedicated to LT has led to a reduction in bleeding and transfusion, with or without the use of viscoelastic testing.\n\nIntraoperative bleeding and transfusion requirements, as well as postoperative thromboembolic complications, remain difficult to predict. Predictive models of bleeding risk have been developed, but they are based solely on preoperative characteristics and do not take into account the course and various phases of the operation. In addition, new methods such as Bayesian inference or machine learning have been developed, and seem capable of providing different information from that obtained by conventional models.\n\nThe overall aim of this prospective multicenter observational study is to investigate the risk factors for bleeding and thrombosis in per- and post-operative LT using different predictive methods, and to describe the management of bleeding and post-operative anticoagulation in metropolitan France.",[29],"RECRUITING","2026-03-27",{"date":83,"type":35},"2026-04-02",{"date":85,"type":35},"2024-10-17",{"date":87,"type":23},"2026-12-31",{"name":89,"class":42},"Société Française d'Anesthésie et de Réanimation",16,{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":67},"100529116","verification-of-risk-factors-of-thrombohemorrhagic-complications-in-recipients-after-related-liver-transplantation-100529116","NCT06169592","Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation","Verification of Prognostic Risk Factors of Thrombohemorrhagic Complications in Early Follow-up Period in Recipients After Living Related Liver Transplantation","VORTAL","Inclusion Criteria:\n\n* Age over 18 years and up to 70 years;\n* Signed informed consent for inclusion to the study;\n* End stage liver cirrhosis.\n\nExclusion Criteria:\n\n* Pregnancy;\n* Extrahepatic factors influencing systemic hemostasis;\n* Concomitant hematological diseases affecting the hemostatic system;\n* Severe concomitant disorders.","70 Years",{"count":101,"type":23},30,"The aim of the study is to improve the results of related transplantation of the right liver lobe by verifying the general predictors of the development of hemostatic system disorders and optimizing a comprehensive program for thrombohemorrhagic complications preventing.",[104,29],"Liver Cirrhosis","2025-12-29",{"date":107,"type":35},"2025-12-30",{"date":109,"type":35},"2022-04-22",{"date":111,"type":23},"2026-12-16",{"name":113,"class":42},"Republican Specialized Scientific and Practical Medical Center of Surgery Named After V. Vakhidov",{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":122,"enrollmentInfo":123,"targetDuration":4,"studyType":24,"phases":125,"briefSummary":127,"conditions":128,"keywords":134,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":150},"100589775","phase-4-strategic-help-with-immunoglobulin-to-enhance-protect-against-late-disease-cmv-100589775","NCT06958796","Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)","Exploratory Use of CMV Immunoglobulin in High Risk (D+R-) Transplant Recipients at the End of Antiviral Prophylaxis to Decrease the Risk of Late CMV Infection","SHIELD","Inclusion Criteria\n\n* High risk pretransplant CMV donor seropositive\u002Frecipient seronegative (D+R-) kidney, liver, or simultaneous liver-kidney (SLK) transplant recipients\n* Able to do routine blood testing (normal care for transplant recipients)\n* Written informed consent obtained from the subject before any trial-related procedures\n* Be ≥18 years and ≤75 years of age at time of consent\n\nExclusion Criteria\n\n* Any pre-transplant CMV serologic combinations besides CMV D+\u002FR-\n* Multi organ transplants (other than simultaneous liver-kidney transplant (SLK) recipients) or prior history of bone marrow or stem cell transplant\n* Lung, heart, small bowel, pancreas, or other non-kidney or non-liver transplant recipients\n* Transplant recipients treated for rejection within three months before the end of valganciclovir prophylaxis\n* Participation in another interventional clinical trial at time of consent or within 30 days prior to study consent\n* Transplant recipients with eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2 (as they theoretically could be at higher risk for renal impairment with CMV immunoglobulin), poor transplant organ function (i.e. LFTs \\> twice the upper limit of normal in liver recipients), or who are on dialysis, or plasmapheresis, or who are relisted for transplant, or who might otherwise at risk of complications at the discretion of the local site investigator.\n* Those with a history of severe reaction to CMV immunoglobulin (e.g. CytoGam® or similar) or other human immunoglobulin preparations\n* Individuals with a history of selective immunoglobulin A deficiency will be excluded, as they may produce antibodies against immunoglobulin A, leading to potential anaphylactic reactions upon receiving blood products containing immunoglobulin A, such as CMV immunoglobulin (e.g. CytoGam® or similar)\n* Any history of acute myocardial infarction (within 12 months of screening), clinically significant arrythmia, or clinically significant ECG abnormality in the opinion of the investigator at time of screening\n* History of active or latent tuberculosis (except those who have completed a documented regimen for latent TB treatment) or severe pulmonary disease \\[e.g., severe pulmonary hypertension (WHO class IV)\\] that in the opinion of the investigator that may preclude their ability to safely tolerate study infusions\n* Any history of neurodegenerative disease, including dementia, or stroke with substantial residual disability (modified Rankin score ≥ 3)\n* Pregnant or nursing (lactating) women confirmed by human chorionic gonadotropin (hCG) laboratory test.\n* Women of childbearing potential unless using a highly effective method of contraception during dosing and for 24 weeks after study treatment. Medically acceptable birth control (contraceptives) includes but are not limited to: surgical sterilization (such as hysterectomy or \"tubes tied\"), approved hormonal contraceptives (such as birth control pills, patch or ring; Depo-Provera, Depo-Lupron, lmplanon), barrier methods (such as condom or diaphragm), an intrauterine device (IUD), abstinence from sex.\n* Any significant history of any treatment nonadherence or any other medical condition that, in the investigator's opinion, would confound the results of the study or put the participant at undue risk\n* Subjects who have any of the following laboratory values: eGFR \\\u003C30 ml\u002Fmin\u002F1.73m2 ; Hemoglobin \\\u003C8.0 g\u002FdL; Platelets \\\u003C50,000 cells\u002FuL; Absolute neutrophil count \\\u003C1,000 cells\u002FuL; Total bilirubin \\>2.5 x upper limit of normal; Alanine aminotransferase (ALT) \\>5 x upper limit of normal; Aspartate aminotransferase (AST)\\] \\>5 x upper limit of normal; CMV IgG negative in donor or positive in recipient","75 Years",{"count":124,"type":23},80,[126],"PHASE4","This study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help transplant recipients with a high risk for developing late CMV disease after a liver and\u002For kidney transplant.",[129,130,131,132,133],"Cytomegalovirus","Organ Transplant","Kidney Transplant; Complications","Liver Transplant Complications","Simultaneous Liver-Kidney Transplantation; Complications",[135,136,137,138,139,140],"cytomegalovirus","valganciclovir","organ transplant","immunoglobulin","CMV","High Risk CMV","2025-12-18",{"date":143,"type":35},"2025-12-22",{"date":145,"type":35},"2025-11-27",{"date":147,"type":23},"2028-05-31",{"name":149,"class":42},"Camille N. Kotton, MD",2,{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":99,"enrollmentInfo":159,"targetDuration":4,"studyType":24,"phases":161,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":67},"100605984","phase-3-darbepoetin-in-patients-candidates-for-liver-transplant-epo-lt-trial-100605984","NCT07169643","Darbepoetin in Patients Candidates for Liver Transplant. (EPO-LT Trial)","Darbepoetin in Patients Candidates for Liver Transplant: Randomized Clinical Trial Protocol. (EPO-LT Trial)","EPO-LT","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Patients on the official liver transplant waiting list\n3. Hemoglobin (Hb) level ≤ 11.5 g\u002FdL\n4. Women of child-bearing potential\\* must have a negative pregnancy test in serum before the inclusion in the study and agree to use highly effective contraceptive methods during the study. Highly effective contraceptive methods will include: intrauterine device, bilateral tubal occlusion, vasectomized partner and sexual abstinence\\*\\* (only if refraining from heterosexual intercourse during the period of twelve months). Hormonal contraceptive methods will be avoided due to the risk of adverse events and impairment of liver function.\n\n   * A woman will be considered of childbearing potential, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as 0 menses for 12 months without an alternative medical cause. A high follicle stimulating hormone level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single follicle stimulating hormone measurement is insufficient. \\*\\* Sexual abstinence should only be used as a contraceptive method if it is in line with the subjects' usual and preferred lifestyle. Periodic abstinence (calendar, symptothermal, post ovulation methods) is not an acceptable method of contraception.\n\nExclusion Criteria:\n\n* 1\\. Acute\u002Fsubacute liver failure (see appendix 7) 2. Patients with acute-on-chronic liver failure grade III and\u002For MELD \\> 35 3. History of thrombosis, including portal vein thrombosis 4. Significant coronary artery disease (requiring angioplasty and\u002For coronary stent) 5. Serum ferritin \\> 800 ng\u002FmL and SAT \\> 50% 6. Anticoagulant\u002Fantiplatelet therapy 7. History of seizures 8. Uncontrolled hypertension (requiring ≥2 antihypertensive drugs) 9. Active infection\u002Fsepsis (see appendix 8) 10. Lack of patient consent. 11. Pregnancy or breastfeeding. 12. Patients included in other clinical trials in the month before inclusion. 13. Patients with mental incapacity, language barrier, bad social support or any other reason considered by the investigator precluding adequate understanding, cooperation or compliance in the study.",{"count":160,"type":23},140,[162],"PHASE3","This is a national multicenter, randomized clinical trial to evaluate the the efficacy and safety of DP administration in patients on the liver transplant waiting list to reduce intraoperative red blood cell concentrate transfusion.",[29],[166],"living kidney trasplant","2025-12-11",{"date":141,"type":35},{"date":170,"type":35},"2025-11-25",{"date":172,"type":23},"2027-06",{"name":174,"class":42},"Fundacion Clinic per a la Recerca Biomédica",{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":183,"enrollmentInfo":184,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":186,"conditions":187,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":195,"locationsCount":197},"100409625","liver-transplantation-in-patients-with-cirrhosis-and-severe-acute-on-chronic-liver-failure-indications-and-outcomes-100409625","NCT04613921","Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure: iNdications and outComEs","Liver Transplantation in Patients With CirrHosis and Severe Acute-on-Chronic Liver Failure (ACLF): iNdications and outComEs","CHANCE","Inclusion Criteria:\n\n* 1\\. Male or female subject ≥18 years of age.\n\n  2\\. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).\n\n  3\\. Subjects who have been hospitalized for acute decompensation of liver cirrhosis and referred to the transplant team:\n* Group 1: patients listed for liver transplantation with ACLF-2 or 3 at the time of listing or developing ACLF 2-3 while on the waiting list.\n* Group 2: patients listed for liver transplantation with decompensated cirrhosis without ACLF-2 or 3 and poor liver function (MELD\\>20) at the time of listing.\n* Group 3: patients having ACLF-2 or 3, are assessed for inclusion in the waiting list, but are finally not listed for liver transplantation.\n\n  4\\. Patients (or trusted person, family member or close relation if the patient is unable to express consent) who have been informed and signed their informed consent Inclusion criteria\n\nExclusion Criteria:\n\n\\-","80 Years",{"count":185,"type":23},3000,"Management of ACLF is mainly supportive. The poor outcomes lead physicians to consider liver transplantation as an option, even if controversial. In sicker recipients, LT results in immediate survival, but poor medium-term survival rates in some studies. The scarcity of deceased donors obliges to maximize LT success. Alternative strategies, as living-donor LT, should be explored. LDLT has impressive results in Eastern centers, but it is restrained in Western countries, due to potential life-threatening complications in the donor.",[57,104,188,29],"Acute-On-Chronic Liver Failure","2025-10-15",{"date":191,"type":35},"2025-10-20",{"date":193,"type":35},"2021-07-08",{"date":87,"type":23},{"name":196,"class":42},"European Foundation for Study of Chronic Liver Failure",106,{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":206,"targetDuration":207,"studyType":77,"phases":4,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":237},"100450503","cytosorb-treatment-of-critically-ill-patients-registry-100450503","NCT05146336","CytOSorb TreatMent Of Critically Ill PatientS Registry","CytOSorb TreatMent Of Critically Ill PatientS Registry: International Registry on the Use of CytoSorb in the Critical Care Setting","COSMOS","Inclusion Criteria:\n\n1. Planned OR actual CytoSorb® 300 mL device utilization\n2. Informed consent for prospective registry participation\n\nExclusion Criteria:\n\n1. Use of the CytoSorb® 300 mL device for antithrombotic removal only\n2. Intraoperative use of CytoSorb® 300 mL device during cardiac surgery only\n3. The occurrence of a complication or other medically justified circumstance that arises after written informed consent has been obtained from the patient and before or during the planned therapy and as a result of which the use of CytoSorb® 300 mL Adsorber is contraindicated or no longer appropriate.",{"count":185,"type":23},"3 Months","Registry intended to provide a data repository and reporting infrastructure for the surveillance of CytoSorb device use in real-world critical care settings, and to serve as an objective, comprehensive, and scientifically-based resource to measure and improve the quality of patient care",[210,211,212,213,214,215,216,217,218,219,220,221,222,29,223,224,225,226],"Septic Shock","Acute Respiratory Distress Syndrome","Trauma","Rhabdomyolysis","Cardiogenic Shock","Pancreatitis","Acute on Chronic Liver Failure","Acute Liver Failure","Burns","Chimeric Antigen Receptor T-Cell Therapy (CAR-T) Cytokine Release Syndrome (CRS)","Extracorporeal Life Support","Postoperative Endocarditis","Hemophagocytic Lymphohistiocytoses","Infectious Disease","Postoperative Vasoplegic Syndrome","Drug Overdose","Sepsis","2025-09-10",{"date":229,"type":35},"2025-09-11",{"date":231,"type":35},"2022-06-22",{"date":233,"type":23},"2032-09",{"name":235,"class":236},"CytoSorbents, Inc","INDUSTRY",28,{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":24,"phases":247,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":254,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":67},"100457876","phase-4-extended-release-tacrolimus-following-liver-transplantation-100457876","NCT05242315","Extended-Release Tacrolimus Following Liver Transplantation","Feasibility, Efficacy And Safety Of De Novo Extended-Release Tacrolimus Following Liver Transplantation","Inclusion Criteria:\n\n\\- Adult individuals transplanted at the University of Alberta\n\nExclusion Criteria:\n\n* Individuals with congenital long QT syndrome\n* Patients with elevated bilirubin \\> 100 umol\u002FL post-LT (at day 3)\n* Patients with chronic kidney disease (eGFR \\\u003C 45 ml per minute per 1.73 m2)\n* Patients with acute kidney injury requiring discontinuation of calcineurin inhibitors.\n* Patients who have hepatocellular carcinoma, require a re-transplant, or receive multi-visceral transplant",{"count":246,"type":23},94,[126],"Medications used after transplant to prevent rejection are associated with many side effects. Tacrolimus side effects include kidney dysfunction; tremor, headaches, difficulty sleeping, change in sensation (legs), seizure, or confusion; high blood pressure; anemia, or low blood cell counts; diabetes; abnormal cholesterol and weight gain. The investigators want to use a new, approved, formulation of the standard medication (Envarsus) as they believe it may be associated with reduced side effects. The investigators would like to assess how safe it is to use this medication and how well it works in comparison to currently used formulations. The investigators will study if there are less side effects and will study clinical outcomes (including how well the liver does and if there is need for hospitalizations after transplant).\n\nThe investigators hope that this information will improve the care provided to and outcomes in patients following liver transplant.",[29,250,251,252,253],"Renal Insufficiency","Immunosuppressant Adverse Reaction","Metabolic Syndrome","Cardiovascular Diseases","2025-08-19",{"date":256,"type":35},"2025-08-21",{"date":258,"type":35},"2022-05-15",{"date":260,"type":23},"2034-02-15",{"name":262,"class":42},"University of Alberta",{"id":264,"slug":265,"hasResults":12,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":270,"enrollmentInfo":271,"targetDuration":4,"studyType":24,"phases":272,"briefSummary":274,"conditions":275,"keywords":277,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":67},"100493103","health-advocate-for-liver-transplant---pilot-100493103","NCT05700799","HEalth Advocate for Liver Transplant - Pilot","HEAL-Tx Pilot","Inclusion Criteria:\n\n1. Patients under 18 years if age that have undergone liver transplantation.\n2. Subject and\u002For parent\u002Flegal guardian can provide written informed consent and willing to comply with study procedures.\n3. Subject and\u002For parent\u002F legal guardian is willing to be contacted in the future by study staff.\n4. Patient and\u002For caregiver felt to be a good fit for this pilot by transplant team.\n\nExclusion Criteria:\n\n* Caregiver unwilling or unable to complete the survey.\n* Child is a ward of the state (e.g. foster care) since present circumstances may not be reflective of child's past or future circumstances.\n* Non-English, non-Spanish speakers.\n* Non-US residents.\n* Greater than 18 years of age at the time of enrollment.","17 Years",{"count":22,"type":23},[273],"NA","The Health Advocate for Liver Transplant (HEAL-Tx) Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for pediatric liver transplant patients and measure acceptability and feasibility according to RE-AIM.",[29,276],"Pediatric ALL",[278,279],"Health Advocate","Patient Navigator","2025-08-14",{"date":282,"type":35},"2025-08-17",{"date":284,"type":35},"2023-03-20",{"date":286,"type":23},"2027-06-30",{"name":288,"class":42},"University of California, San Francisco",{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":99,"enrollmentInfo":296,"targetDuration":4,"studyType":24,"phases":298,"briefSummary":299,"conditions":300,"keywords":302,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":67},"100603144","the-efficacy-of-intravenous-amino-acids-in-reducing-the-occurrence-of-aki-after-live-donor-liver-transplant-100603144","NCT07132697","The Efficacy of Intravenous Amino Acids in Reducing the Occurrence of AKI After Live Donor Liver Transplant","The Efficacy of Intravenous Amino Acids in Reducing the Occurrence of AKI After Live Donor Liver Transplant: An Open Label Randomized Trial","Inclusion Criteria\n\n1. All LDLT Recipient\n2. Age: \\> 18 years\n3. Signed informed consent\n\nExclusion Criteria\n\n1. Negative consent.\n2. Pediatric LDLT.\n3. ALF patient undergoing LDLT.\n4. Patients on intermittent or continuous renal replacement therapy.\n5. Patients with eGFR less then 40 ml per min per 1.73 m2.\n6. SLKT and prior Kidney transplant.\n7. Patient has a hypersensitivity (known allergy) to one or more of the included amino acids.\n8. Patient has a known congenital alteration of amino acid metabolism.",{"count":297,"type":23},100,[273],"This prospective, open-label, randomized controlled trial aims to evaluate the efficacy of intravenous amino acid infusion in reducing AKI after LDLT. Eligible adult patients undergoing LDLT will be randomized into two groups: one receiving Continuous infusion of a L-amino acids mixture in a dose of 2 g\u002Fkg dry body weight\u002Fday (to a maximum 100 g\u002Fday) after induction of anesthesia and insertion of CVP line till 72 hours after treatment initiation, and the other receiving standard management. The primary outcome is the incidence of AKI as per KDIGO criteria within 7 days of transplant.",[29,301],"AKI - Acute Kidney Injury",[303],"Liver Transplantation, Acute Kidney Injury, Amino Acids, KDIGO, NGAL, Randomized Controlled Trial","2025-08-13",{"date":306,"type":35},"2025-08-20",{"date":308,"type":23},"2025-08-25",{"date":310,"type":23},"2026-09-01",{"name":312,"class":42},"Institute of Liver and Biliary Sciences, India",{"id":314,"slug":315,"hasResults":12,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":18,"minAge":320,"maxAge":321,"enrollmentInfo":322,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":67},"100519814","placement-of-biliary-drainage-stent-to-prevent-biliary-intestinal-anastomosis-after-liver-transplantation-in-children-100519814","NCT06048445","Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children","Placement of Biliary Drainage Stent to Prevent Biliary Intestinal Anastomosis After Liver Transplantation in Children: A Prospective Study","Inclusion Criteria:\n\n1. The patient underwent liver transplantation surgery at the First Affiliated Hospital of Zhejiang University School of Medicine;\n2. Age ≤ 6 years old;\n3. First liver transplantation;\n4. Willing to sign an informed consent form.\n\nExclusion Criteria:\n\n\\- Existence of mental illnesses that can affect cognition and coordination.","1 Year","6 Years",{"count":323,"type":23},108,"Liver transplantation is an effective method for treating end-stage liver disease and metabolic diseases in children. With the advancement of surgical techniques and the improvement of perioperative management, the survival rates of patients and grafts after liver transplantation have significantly improved. However, the complication of biliary stenosis after transplantation is as high as 7.3% -33.3%, and in severe cases, it can even lead to graft failure and patient death. Therefore, the occurrence of biliary stenosis after liver transplantation seriously affects the quality of life of children, increases the economic burden on families, and urgently needs to find effective methods to reduce the occurrence of this complication.\n\nBased on the clinical practice of our center, we believe that the placement of biliary external drainage stents has the following advantages: 1 Reduce intrahepatic biliary pressure and reduce the occurrence of postoperative biliary fistula; 2. The stent has a supporting effect and can maintain the open state of the bile duct; 3. By external drainage, the quality of bile secretion by the liver can be evaluated; 4. Provide a pathway for cholangiography. However, placing external biliary drainage may also pose certain risks, including increasing surgical procedures, stent detachment causing biliary fistula, and increasing the risk of infection.\n\nThis study aims to observe the effect of placing external biliary drainage stents on biliary stricture after liver transplantation in children. The aim is to evaluate the preventive effect of external biliary drainage stents on biliary intestinal anastomotic stenosis after liver transplantation in children, and to provide evidence-based evidence for reducing biliary complications in children.",[29],"2025-08-05",{"date":328,"type":35},"2025-08-11",{"date":330,"type":35},"2023-02-07",{"date":332,"type":23},"2027-12-31",{"name":334,"class":42},"Zhejiang University",{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":339,"acronym":340,"eligibilityCriteria":341,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":99,"enrollmentInfo":342,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":344,"conditions":345,"keywords":346,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":67},"100526077","mr-proadm-as-a-early-biomarker-for-dgf-and-ar-in-kidney-and-liver-transplantation-100526077","NCT06130046","MR-proADM as a Early Biomarker for DGF and AR in Kidney and Liver Transplantation","DARE","Inclusion Criteria:\n\n* Kidney transplant recipient at our Institution\n* Liver transplant recipient at our Institution\n\nExclusion Criteria:\n\n* Re-transplantation\n* Dual kidney transplantation\n* Combined transplant (kidney-liver, kidney-pancreas)\n* Autoimmune disease as indication to transplant",{"count":343,"type":23},300,"To define the sensibility and the specificity of increased levels of MR-proADM for early, non-invasive, diagnosis of AR and DGF after kidney and liver transplantation creating a predictive model for related complications after kidney and liver transplantation based on the pre-operative and post-operative levels of MR-proADM and by a machine learning process.",[131,29],[347,348,349,350,351,352],"MR-proADM","Adrenomedullin","Kidney Transplantation","Liver Transplantation","DGF","Acute rejection","2025-07-29",{"date":355,"type":35},"2025-08-01",{"date":357,"type":35},"2022-12-01",{"date":359,"type":23},"2026-12-01",{"name":361,"class":42},"University of Rome Tor Vergata",{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":4,"eligibilityCriteria":368,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":50,"enrollmentInfo":369,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":371,"conditions":372,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":150},"100346335","risk-factors-and-outcome-of-biliary-complications-following-adult-living-donor-liver-transplantation-100346335","NCT03789383","Risk Factors and Outcome of Biliary Complications Following Adult Living Donor Liver Transplantation","Risk Factors and Outcome of Biliary Complications Following Adult Living Donor Liver Transplantation in Al-Rajhy Liver Hospital in Upper Egypt.","Inclusion Criteria:\n\n* Adults more than 18 y with living donor liver transplantation in Al-Rajhy liver hospital , Assiut university,Egypt\n\nExclusion Criteria:\n\n* pediatric liver transplantation\n* cadaveric liver transplantation",{"count":370,"type":23},50,"Liver transplantation (LT) is a live-saving therapy for patients with complicated chronic liver diseases and acute liver failure .Even though many complications can occur after LT, biliary complications (BC) are both common and potentially severe .\n\na prospective study and retrospective part from hospital records.\n\nAim of the study:\n\n1. Detect frequency, risk factors for development of biliary complications post living donor liver transplantation, types (stricture anastomotic or not, leak, biloma, stone, cholangitis etc.…).\n2. Evaluate outcomes of different biliary complications",[29],"2025-07-21",{"date":375,"type":35},"2025-07-24",{"date":377,"type":35},"2024-01-01",{"date":379,"type":23},"2027-07-01",{"name":381,"class":42},"Assiut University",{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":4,"eligibilityCriteria":388,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":122,"enrollmentInfo":389,"targetDuration":4,"studyType":24,"phases":390,"briefSummary":391,"conditions":392,"keywords":397,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":67},"100585645","phase-2-pharmacologic-approaches-to-preventing-primary-sclerosing-cholangitis-recurrence-after-liver-transplantation-100585645","NCT06905054","Pharmacologic Approaches to Preventing Primary Sclerosing Cholangitis Recurrence After Liver Transplantation","Peroxisome Proliferator-Activated Receptor Agonists to Prevent Primary Sclerosing Cholangitis Recurrence After Liver Transplantation","Inclusion criteria:\n\n* Adults aged 18-75 irrespective of gender who have undergone LT for PSC or PSC-related liver malignancy between 1 year and 7 years (inclusive) prior to study enrollment\n* Absence of rPSC at time of study enrollment\n* At least one of the following additional features that increase risk of rPSC\n\n  * LT performed for cholangiocarcinoma\n  * Concurrent inflammatory bowel disease\n  * Any episode of cytomegalovirus viremia in the post-transplant period before study enrollment\n  * Any episode of acute cellular rejection in the post-transplant period before the study enrollment\n* If target enrollment of 40 patients is not achieved during the first 6 months of study, we will remove f(iii) inclusion criteria to expand enrollment to any patient meeting the other inclusion\u002Fexclusion criteria.\n* Due to lab requirements, we will only enrol patients who are within a 3 hour driving distance of Mayo Clinic Arizona and\u002For are willing to travel to Mayo Clinic Arizona at 4 month intervals during the study at own cost.\n\nExclusion criteria:\n\n* Presence of ischemic cholangiopathy which can mimic rPSC\n* LT performed for primary biliary cholangitis or autoimmune hepatitis, or PSC with overlapping primary biliary cholangitis or autoimmune hepatitis, which may recur after LT and confound assessment of cholestasis\n* Unaddressed post-LT hepatic artery compromise (e.g thrombosis, stenosis) which can mimic rPSC\n* History of total colectomy for curative treatment of ulcerative colitis which reduces risk of rPSC\n* Baseline GFR \\\u003C30 ml\u002Fmin which precludes administration of fenofibrate\n* Previously known intolerance or allergy to fenofibrate\n* Other clinically significant comorbid condition, including inability to provide consent and psychiatric conditions, which in the opinion of the study team, may interfere with patient treatment, safety, assessment, or compliance with the treatment\n* Female participants that are pregnant or planning to become pregnant",{"count":124,"type":23},[26],"This study aims to determine the efficacy of 36 months once-daily fenofibrate in preventing clinically-detectable recurrence of primary sclerosing cholangitis after liver transplantation, compared with a historical control cohort that was not treated with",[393,394,395,396],"Primary Sclerosing Cholangitis","Liver Transplant, Complications","PSC","Biliary Strictures",[398,399,400,401,402,403,404],"primary sclerosing cholangitis","recurrent primary sclerosing cholangitis","liver transplant complication","fenofibrate","fibrate","PPAR agonist","peroxisome proliferated activated receptor agonist","2025-06-25",{"date":407,"type":35},"2025-06-27",{"date":409,"type":35},"2025-04-15",{"date":411,"type":23},"2028-07-01",{"name":66,"class":42},{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":419,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":18,"minAge":421,"maxAge":4,"enrollmentInfo":422,"targetDuration":4,"studyType":24,"phases":423,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":427,"lastUpdatePostDateStruct":428,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":67},"100520732","effect-of-oral-semaglutide-on-liver-fat-and-body-composition-in-liver-transplant-recipients-with-diabetes-mellitus-100520732","NCT06060392","Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus","Effect of Oral Semaglutide on Liver Fat and Body Composition in Liver Transplant Recipients With Diabetes Mellitus: Sema-Lit","Sema-Lit","Inclusion Criteria:\n\n1. A man or woman, 30 years of age or above with liver transplantation of at least 3 months duration who meets all the following two criteria:\n\n   1. On standard anti-diabetic agents (metformin and\u002For insulin) with an HbA1c of \\\u003C=9% at screening\n   2. Body mass index of \\>25 kg\u002Fm2\n2. Subjects must be medically stable based on medical history, physical examination, and laboratory investigations.\n3. Subjects must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.\n4. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose of the study and are willing to participate in the study.\n\nExclusion Criteria:\n\n1. History of diabetic ketoacidosis, type 1 diabetes, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy.\n2. History of brittle or labile glycemic control, with widely varying glucose measurements by FPG or SMBG such that stable glucose control over the treatment period would be unlikely.\n3. History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-V) criteria within 3 years before Screening, or an Alcohol Use Disorders Identification Test (AUDIT) with a score \\>=8, or alcohol consumption of more than 20 g per day in the case of women and more than 30 g per day in the case of men for at least three consecutive months during the previous 5 years.\n4. Thyroid stimulating hormone (TSH) value that is either \\\u003C 0.45 mIU\u002FL or \\>10 mIU\u002FL at Screening.\n\n   Note: Subjects on thyroid hormone replacement therapy must be on a stable dose and dosing regimen for at least 4 weeks prior to enrollment.\n5. Use of a PPAR-γ agonist \\[e.g., a thiazolidinedione (pioglitazone\\], an SGLT2 inhibitor (e.g., canagliflozin, empagliflozin, dapagliflozin) or GLP-1 receptor agonists (e.g., liraglutide, dulaglutide) within 12 weeks before the enrollment.\n6. Ongoing eating disorder, or a significant weight loss or weight gain within 12 weeks before the Screening visit, defined as an increase or decrease of 5% in body weight based upon clinic-based measurement or, if not available, based on subject's report.\n7. Myocardial infarction, unstable angina, pulmonary hypertension, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 3 months before Screening, or revascularization procedure is planned, or subject has a history of New York Heart Association (NYHA) Class III-IV cardiac disease.\n8. Use of vitamin E within 4 weeks before screening.\n9. History of prior bariatric (e.g., Roux-en-Y gastric bypass) or other major upper gastrointestinal surgical procedure (including gastric resection).\n10. History of diabetic gastroparesis (or symptoms suggestive of this disorder, including postprandial bloating or vomiting), malabsorption, inflammatory bowel disease, or any other chronic, clinically important gastrointestinal disorder.\n11. Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1•73 m2 using the Modification of Diet in Renal Disease Study (MDRD) equation.\n12. Subjects with a history of having or possibly having metallic material in the body or any contraindication for a MR examination.\n13. Claustrophobia, or anxiety related to previous negative experiences with magnetic resonance imaging procedures or if the subject is unwilling to participate in magnetic resonance imaging procedures.\n14. Clinically important hematologic disorder (e.g., symptomatic anemia, proliferative bone marrow disorder, thrombocytopenia) at Screening.\n15. History of human immunodeficiency virus (HIV) antibody positive at Screening.\n16. Contraindications to the use of oral semaglutide (per ORAL SEMAGLUTIDE Prescribing Information).\n17. Pregnancy or women breastfeeding or planning to become pregnant while enrolled in this study.\n18. History of significant cardiac, vascular, pulmonary, renal, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric disturbances.\n19. Patients with history of myopathies or evidence of active muscle disease.","30 Years",{"count":370,"type":23},[273],"Nonalcoholic fatty liver disease (NAFLD) is a spectrum of liver conditions ranging from liver steatosis (NAFL), steatohepatitis (NASH), advanced liver fibrosis and ultimately leads to cirrhosis in a significant proportion of individuals. NAFLD is intimately associated with insulin resistance and associated disorders, such as obesity, type 2 diabetes, metabolic syndrome, and dyslipidemia.\n\nIt has been noted that several individuals with liver transplantation develop nonalcoholic fatty liver disease in the transplanted liver. This is because of the presence of various risk factors of obesity and NAFLD, such as decreased physical activity, that persist following liver transplantation. Post-liver transplant patients are particularly at risk for developing NAFLD, as these patients are on oral steroids and immunosuppressants for a significant period of time.\n\nThere is no medication approved for the prevention or treatment of NAFLD. Semaglutide is an GLP-1 receptor agonist that have been approved for the treatment of type 2 diabetes and obesity. Semaglutide has also been demonstrated to have beneficial effects on NAFLD. However, there is no data on the effect of semaglutide on liver fat accumulation or changes in body composition in patients following liver transplantation. Therefore, the current pilot study is planned to evaluate the effect of oral semaglutide on the liver fat, liver enzymes and body composition in patients undergoing liver transplantation",[29,426],"Diabete Mellitus","2025-06-12",{"date":429,"type":35},"2025-06-13",{"date":431,"type":35},"2023-10-30",{"date":433,"type":23},"2025-11-01",{"name":435,"class":42},"Medanta, The Medicity, India",{"id":437,"slug":438,"hasResults":12,"nctId":439,"briefTitle":440,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":24,"phases":445,"briefSummary":446,"conditions":447,"keywords":448,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":150},"100545768","health-advocate-for-liver-transplantation-improving-transition-of-care-for-adolescent-liver-transplant-recipients-100545768","NCT06386198","HEalth Advocate for Liver Transplantation: Improving Transition of Care for Adolescent Liver Transplant Recipients","HEAL-Tx:ToC","Inclusion Criteria:\n\n1. Patient has received a liver transplant \\>1 year ago\n2. Study team has screened patient and discussed with the primary transplant practitioner that patient may benefit from the Health Advocate program.\n3. Patient has an unmet social risk (e.g., food insecurity) or MLVI \\>\u002F= 2.0.\n4. Patient will be transferred to adult transplant team in \\\u003C6 months.\n5. Patient can read and write English or Spanish\n6. Patient is between 18-25 years old and can provide informed consent.\n7. Patient has a working phone and smart device capable of video and\u002For audio virtual visits via Zoom.\n\nExclusion Criteria:\n\n* Patient has significant cognitive impairment.\n* Does not meet age criteria\n* Patient is a ward of the state.\n* Non-English, non-Spanish speakers.\n* Non-US residents.","25 Years",{"count":52,"type":23},[273],"The Health Advocate for Liver Transplant (HEAL-Tx) Transition of Care Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team to help adolescents transition their care to adult transplant teams. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for adolescent\u002Fyoung adult liver transplant patients and measure acceptability and feasibility according to RE-AIM.",[29,276],[278,279],"2025-05-07",{"date":451,"type":35},"2025-05-13",{"date":453,"type":35},"2024-03-03",{"date":455,"type":23},"2026-06-30",{"name":288,"class":42},{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":24,"phases":467,"briefSummary":468,"conditions":469,"keywords":471,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":67},"100578257","preoperative-prehabilitation-in-patients-planned-for-liver-transplantation-100578257","NCT06808945","Preoperative Prehabilitation in Patients Planned for Liver Transplantation","Preoperative PREhabilitation in Patients Planned for LIVER Transplantation (PRELIVERT)","PRELIVERT","Inclusion Criteria:\n\n* Age ≥18 years,\n* Anticipated waitlisting for LT,\n* Speaks the Dutch language,\n* Understands the purpose of the study and has given written informed consent.\n\nExclusion Criteria:\n\n* Experienced a major adverse cardiovascular event in the past six months,\n* Experienced a cerebrovascular incident in the past six months,\n* Medical history of an uncontrolled heart rhythm disorder,\n* Hepatic encephalopathy grade 3 or 4,\n* Acute liver failure,\n* Acute-on-chronic liver failure,\n* Hospitalization at start of the study.\n* Non-treated esophageal varices (i.e., no previous variceal eradication endoscopy or adequately dosed NSBB)",{"count":466,"type":23},60,[273],"The objective of this study is to determine the feasibility and effectiveness of a home-based multimodal prehabilitation program in patients anticipated to be waitlisted for LT. Patients will participate in an eight week prehabilitation program consisting of physical exercise, nutritional support, smoking cessation and psychological counselling.",[29,470],"Physical Inactivity",[472,473],"prehabilitation","liver transplant","2025-02-04",{"date":476,"type":35},"2025-02-05",{"date":478,"type":35},"2024-10-02",{"date":480,"type":23},"2026-07",{"name":482,"class":42},"Erasmus Medical Center",{"id":484,"slug":485,"hasResults":12,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":24,"phases":493,"briefSummary":494,"conditions":495,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":504,"locationsCount":67},"100571153","biodegradable-stents-in-liver-transplant-recipients-for-treatment-of-biliary-anastomotic-strictures-100571153","NCT06716541","Biodegradable Stents in Liver Transplant RecipIents for Treatment of Biliary Anastomotic Strictures","Biodegradable Stents Versus Plastic Stents for Treatment of Biliary Anastomotic Strictures in Liver Transplant RecipIents","BRILLIANT","Inclusion Criteria:\n\n* Age ≥18 years\n* Liver transplant recipients\n* Duct-to-duct biliary anastomosis\n* Anastomotic biliary stricture (cholestasis unexplained by other causes and\u002For liver biopsy showing altered biliary drainage and\u002For anastomotic stricture on MRCP)\n* Signed informed consent\n\nExclusion Criteria:\n\n* Hepaticojejunoanastomosis\n* Physical and\u002For psychological inability to understand the aims of the research and to adequately cooperate\n* Pregnancy",{"count":492,"type":23},70,[273],"Biliary complications after liver transplantation (LT) remain common and are associated with higher morbidity in liver transplant recipients and liver graft failure. Anastomotic biliary strictures are the most common biliary strictures after LT. Today, the gold standard for treatment remains endoscopic retrograde cholangiopancreatography (ERCP) with either multiple plastic stenting (MPS) or fully covered metal stents. These methods have disadvantages such as the need for repeated ERCP procedures, high costs or the risk of migration.\n\nBiodegradable stents (BDS) are a novel type of stents made from various synthetic polymers or their copolymers, which are now being used in a variety of medical fields, including the pancreatobiliary tract.The use of biodegradable stents has shown good potential in the treatment of benign biliary strictures. However, overall data on their endoscopic use in liver transplant recipients, particularly in the treatment of anastomotic biliary strictures, are scarce. Most studies have either been in animal models, using percutaneously implanted stents, or in non-transplanted patients. There are no randomised controlled trials investigating their use in LT patients. Based on the available evidence, the use of BDS in the treatment of anastomotic biliary strictures in liver transplant recipients appears to be a promising technique that may be as effective as the standard treatment with MPS, but may reduce the number of ERCP procedures and eliminate the risk of migration.\n\nThe aim of this randomised prospective study is to compare the difference in rates of anastomotic stricture resolution between the active (BDS) and control (MPS) groups to demonstrate non-inferiority of the biodegradable stents. Outcomes will be classified as complete resolution (no significant stricture at the anastomotic site on imaging and resolution of cholestasis), significant response (relative stricture and resolution of cholestasis) or failure (persistent stricture and\u002For persistent cholestasis). Secondary outcomes are technical feasibility, immediate and late complications.",[394,496,497],"Biliary Anastomotic Stenosis","Endoscopic Retrograde Cholangiopancreatography","2024-12-03",{"date":500,"type":35},"2024-12-04",{"date":502,"type":35},"2024-11-01",{"date":332,"type":23},{"name":505,"class":506},"Institute for Clinical and Experimental Medicine","OTHER_GOV",{"id":508,"slug":509,"hasResults":12,"nctId":510,"briefTitle":511,"officialTitle":512,"acronym":4,"eligibilityCriteria":513,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":122,"enrollmentInfo":514,"targetDuration":4,"studyType":24,"phases":516,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":522,"lastUpdatePostDateStruct":523,"startDateStruct":525,"completionDateStruct":527,"leadSponsor":529,"locationsCount":67},"100557090","the-effect-of-the-type-of-conduit-duct-anastomosis-technique-on-the-postoperative-course-in-patients-undergoing-liver-transplantation-100557090","NCT06533592","The Effect of the Type of Conduit-duct Anastomosis Technique on the Postoperative Course in Patients Undergoing Liver Transplantation","A Prospective Randomized Study to Evaluate the Effect of the Type of Conduit-duct Anastomosis Using the Single\u002Fcontinuous Suture Technique on the Postoperative Course in Patients Undergoing Liver Transplantation from a Deceased Donor.","Inclusion Criteria:\n\n* age over 18\n* elective liver transplantation\n* informed consent to participate in the study\n* recipient bile duct diameter over 3mm\n* donor bile duct diameter over 3mm\n\nExclusion Criteria:\n\n* age below 18\n* pregnancy\n* living donor liver transplantation\n* split-liver or reduced-size liver transplantation\n* liver transplantation other than from brain death donor\n* liver transplantation with hepaticojejunostomy\n* patients undergoing re-transplantation\n* multi-organ transplantation\n* recipient bile duct diameter below 3mm\n* donor bile duct diameter below 3mm",{"count":515,"type":23},284,[273],"The main objective of the trial is to compare the effect of two end-to-end duct-to-duct anastomosis surgical techniques using the continuous suture method versus interrupted method (control group) on reducing the risk of bile leakages in the 90-day follow-up period after liver transplantation and other postoperative complications resulting from them i.e.: the occurrence of a critical stenosis in the duct-to-duct anastomosis within 90 days. In addition, as part of the research experiment, long-term biliary complications will be assessed, i.e. occurring over a period of more than 90 days (a 2-year observation period of patients was assumed).\n\nAs part of the trial 284 patients qualified for the procedure of liver transplantation from a deceased donor will be included, in whom end-to-end anastomosis of the bile ducts will be performed. After entering the study, patients will be randomized to one of the groups. In the group of 142 patients, duct-to-duct anastomosis will be performed using an interrupted suture (control group), and the remaining patients will be performed using the continuous suture technique.\n\nThe analysis will also include surgical complications, complications related to early and late graft function, retransplantation and overall survival.\n\nAdditionally the analyses an analysis of the impact of the occurrence of a biliary complication on the quality of life of patients after liver transplantation will be performed on the basis of the EORTC QLQ-C30 forms.\n\nThe period of observation of the patient after the procedure is planned for 24 months.",[29,519,520,521],"Bile Duct; Stricture, Postoperative","Bile Leak","Quality of Life","2024-10-21",{"date":524,"type":35},"2024-10-24",{"date":526,"type":35},"2024-09-28",{"date":528,"type":23},"2028-09-01",{"name":530,"class":42},"Medical University of Warsaw",{"id":532,"slug":533,"hasResults":12,"nctId":534,"briefTitle":535,"officialTitle":536,"acronym":4,"eligibilityCriteria":537,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":538,"targetDuration":4,"studyType":24,"phases":540,"briefSummary":541,"conditions":542,"keywords":545,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":550,"lastUpdatePostDateStruct":551,"startDateStruct":553,"completionDateStruct":555,"leadSponsor":557,"locationsCount":67},"100563420","effects-of-aerobic-and-resistance-exercises-on-inpatients-liver-transplantation-recipients-100563420","NCT06615934","Effects of Aerobic and Resistance Exercises on Inpatients Liver Transplantation Recipients","Comparing the Effects of Aerobic and Resistance Exercises With Routine Physiotherapy in Inpatients Immediately After Liver Transplantation on Muscle Strength, Functional and Aerobic Capacity, and Blood Biomarkers","Inclusion Criteria:\n\n1. Patients who undergo elective surgery after the approval of the liver transplant commission.\n2. Having an underlying liver disease with metabolic disorder (as determined by the Liver Transplantation Commission)\n3. Absence of transplantation of other organs\n4. No re-transplantation of the liver\n5. Age more than 18 years\n6. Ability to participate in initial evaluations\n7. Patient's ability to understand questionnaire questions\n\nExclusion Criteria:\n\n1. The patient's lack of satisfaction with continuing cooperation for any reason\n2. Re-transplantation up to 3 months after discharge\n3. Facing the patient with early allograft dysfunction or primary nonfunction\n4. Encountering the criteria of non-implementation of the intervention during 50% of the days of stay in the hospital or more\n5. Patients with Postoperative respiratory failure (Extubation \\> 48 hours)",{"count":539,"type":23},40,[273],"The prevalence of chronic liver disease and primary liver cancer is still increasing on a global scale, and so are their associated deaths.\n\nCompared to other diseases, death from liver disease often means premature death, because two-thirds of the lives lost are working years.\n\nLiver transplantation (LT) is an important and life-saving treatment option for the treatment of congenital metabolic disorders, acute liver failure, end-stage chronic liver disease (ESLD) and primary liver cancers.\n\nModern liver transplantation is characterized by significant improvements in post-transplant patient survival, graft survival, and quality of life.\n\nImpaired physical fitness of patients with end-stage liver disease often persists after liver transplantation and compromises post-transplant recovery.\n\nPrior to liver transplantation, excess ammonia taken up by skeletal muscle is a major metabolic driver of muscle wasting in end-stage liver disease and mainly inhibits the mTOR signaling pathway that supports muscle protein synthesis.\n\nBecause excess ammonia is no longer present after transplantation, recovery of muscle mass and function can be expected in patients. However, immunosuppression with calcineurin inhibitors that inhibit the mTOR signaling pathway may improve lethal length.\n\nIt is also thought that post-transplant treatment regimens contribute to delayed recovery of decreased bone mineral density and increased fracture risk.\n\nGreater muscle mass, as measured by creatinine clearance at 1 year after transplantation, was associated with longer recipient and allograft survival.\n\nThe results of previous studies indicate low cardiovascular fitness in patients after liver transplantation.\n\nSince after liver transplantation, cardiovascular diseases cause 19 to 42% of deaths not related to the liver, performing aerobic exercises to obtain and maintain cardiovascular fitness after liver transplantation can reduce the mortality rate. After transplanting, reduced significantly.\n\nConsidering the important role of the immune system in transplant rejection, the safety of sports training is very important in terms of not over-activating the immune system and endangering the life of the transplanted tissue. In previous studies related to exercise and immune system activity and inflammatory cytokines after transplantation, it has been shown that moderate exercise including aerobic and resistance exercises can inhibit inflammatory cytokines and have beneficial effects on the immune system.\n\nHigh levels of tumor necrosis factor-alpha (TNF-α) in the period after transplant surgery are associated with an increased risk of transplant rejection.\n\nAerobic exercise reduces levels of inflammatory cytokine TNF-α and markers of liver function in patients with chronic liver diseases.\n\nAccording to this evidence, it seems that doing sports exercises is effective in reducing the risk of transplant rejection and modulating the patient's immune system. Acute graft rejection occurs days to weeks after transplantation. The immune system can see the transplanted organ as foreign and attack it, destroy it and lead to transplant rejection.\n\nConsidering the mentioned benefits of exercise therapy after liver transplantation, it is possible that the early start of exercise therapy in the hospitalization phase leads to a reduction in the risk of transplant rejection and improvement of allograft residues in patients after liver transplantation.\n\nConsidering that the current evidence shows that there is no use of a specific rehabilitation protocol in the hospitalization phase of patients after liver transplantation, we intend to evaluate its effects with changes in the common physiotherapy program in these departments according to the specific conditions of these patients. In other words, despite the acceptable therapeutic effects, the use of a combined protocol of aerobic and resistance exercises in the hospitalization phase of these patients has not been reported so far.",[543,29,544],"Liver Transplant Disorder","End-stage Liver Disease",[546,547,548,549],"physiotherapy","aerobic exercise","resistance exercise","liver transplant recipients","2024-09-26",{"date":552,"type":35},"2024-09-27",{"date":554,"type":23},"2024-10-01",{"date":556,"type":23},"2025-01-15",{"name":558,"class":42},"Tehran University of Medical Sciences",{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":564,"acronym":565,"eligibilityCriteria":566,"healthyVolunteers":12,"sex":18,"minAge":567,"maxAge":19,"enrollmentInfo":568,"targetDuration":4,"studyType":24,"phases":569,"briefSummary":570,"conditions":571,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":150},"100462972","pediatric-liver-transplantation-liver-fibrosis-evaluation-by-using-fibrosis-panel-100462972","NCT05308628","Pediatric Liver Transplantation-Liver Fibrosis Evaluation by Using Fibrosis Panel","Effect of the Fibrosis Panel on the Evaluation of Allograft Fibrosis After Pediatric Liver Transplantation","PT-LiFE","Inclusion Criteria:\n\n* Male or female participant must be between 8 weeks and 18 years of age.\n* Participant is a recipient of a first liver allograft from cadaveric or living donors.\n* Participant is a single-organ recipient (liver only).\n* Participants' parent\u002Fguardian is capable of understanding the purposes and risks of the study and must sign an informed consent for the study.\n\nExclusion Criteria:\n\n* Participants older than 18 years of age\n* Pregnant or breastfeeding\n* Active systemic infections\n* Receiving any form of solid organ retransplantation\n* Multiorgan transplantation\n* Multi organ failure\n* Congenital sufferers from heart, lung, kidney, nervous system or blood disease\n* Refused to participate the study","2 Months",{"count":76,"type":23},[273],"Liver transplantation in children is highly successful with \\>80% having 20 years survival. Most pediatric liver diseases are potentially curable with liver transplantation and it is important to establish whether children who have undergone successful transplantation can expect a normal life expectancy or whether there will be a gradual decline in liver function and eventual graft loss. The most common reasons in late graft loss in children are unexplained graft inflammation (\"idiopathic\" post-transplant hepatitis) and graft fibrosis. PRO-C3, a disintegrin and metalloproteinase with thrombospondin motifs-generated neo-epitope marker of type III collagen formation, has been proved to be a marker of fibrosis in patients with NAFLD. The aim of this study is to explore the role of Fibrosis Panel(PRO-C3, PIIINP, TIMP-1, HA) in children received liver transplantation.",[572,573,29],"Liver Fibrosis","Pediatric Disorder","2024-08-05",{"date":576,"type":35},"2024-08-07",{"date":578,"type":35},"2022-04-30",{"date":580,"type":23},"2025-11-30",{"name":582,"class":42},"RenJi Hospital",{"id":584,"slug":585,"hasResults":12,"nctId":586,"briefTitle":587,"officialTitle":588,"acronym":589,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":18,"minAge":591,"maxAge":50,"enrollmentInfo":592,"targetDuration":4,"studyType":77,"phases":4,"briefSummary":593,"conditions":594,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":4},"100557807","left-lobe-versus-right-lobe-in-adult-living-donor-liver-transplantation-in-borderline-grwr-100557807","NCT06542913","Left Lobe Versus Right Lobe in Adult Living Donor Liver Transplantation in Borderline GRWR","Left Lobe Versus Right Lobe in Adult Living Donor Liver Transplantation in Borderline GRWR: Prospective Cohort Study","LDLT","Inclusion Criteria:\n\n* GRWR below 1\n\nExclusion Criteria:\n\n* patients with renal impairment portal vein thrombosis vascular complications","16 Years",{"count":101,"type":23},"a prospective cohort study comparing outcomes of left lobe and right lobe adult living donor liver transplantation",[29],"2024-08-03",{"date":576,"type":35},{"date":598,"type":23},"2024-09-15",{"date":600,"type":23},"2026-06-15",{"name":602,"class":42},"Ain Shams University",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":610,"sex":611,"minAge":612,"maxAge":613,"enrollmentInfo":614,"targetDuration":4,"studyType":24,"phases":616,"briefSummary":617,"conditions":618,"keywords":4,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":624,"completionDateStruct":626,"leadSponsor":628,"locationsCount":67},"100546884","phase-1-safety-of-dnp007-in-healthy-subjects-100546884","NCT06400771","Safety of DNP007 in Healthy Subjects","Exploratory, Single-dose, Phase I Clinical Trial to Evaluate the Safety, Tolerability and Pharmacokinetics of DNP007 in Healthy Subjects","Inclusion Criteria:\n\n* A person whose weight at the time of the screening test is between 50.0 kg and 95 kg and whose body mass index (BMI) is between 18.0 kg\u002Fm2 and 30.0 kg\u002Fm2\n* After receiving sufficient explanation and fully understanding this clinical trial, I voluntarily decided to participate. A person who has made a decision and agreed in writing to follow the precautions\n* This test is determined by the examiner through physical examination, clinical laboratory tests, and questionnaires. Persons suitable as test subjects\n\nExclusion Criteria:\n\n* Clinically significant hepatobiliary system (severe liver failure, viral hepatitis, etc.), kidney (severe renal impairment, etc.), nervous system, immune system, respiratory system, endocrine system, blood\u002Ftumor, cardiovascular system (heart failure, etc.), urinary system, Those who have or have a history of mental illness (mood disorder, obsessive-compulsive disorder, etc.), sexual dysfunction, etc\n* Persons with a history of gastrointestinal disease (Crohn's disease, ulcer, gastritis, stomach cramps, gastroesophageal reflux disease, etc.) or surgery (excluding simple appendectomy or hernia surgery) that may affect the safety evaluation of clinical investigational drugs\n* Persons with a history of related allergy or hypersensitivity (including allergy to aspirin, antibiotics, vaccines, test drugs or their excipients)\n* C-reactive protein (CRP) and erythrocyte sedimentation rate in screening tests (ESR) exceeds 1.5 times the upper limit of normal range\n* Those with positive serological test results (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test\n* A person who has developed an infection or disease within 7 days prior to the first administration of the investigational drug (\"disease\" refers to an acute \\[severe or non-severe\\] condition \\[e.g., influenza or common cold, etc.\\])\n* Those who have a history of drug abuse or who have tested positive for drugs of abuse in a urine drug screening test\n* A person who has taken any prescription drug or herbal medicine within 2 weeks before the scheduled date of first administration of the investigational drug, or who has taken any over-the-counter drug (OTC drug) or health functional food or vitamin preparation including liver function supplements within 1 week (however, the investigator's Depending on the judgment, if other conditions are reasonable, you can be selected as a test subject) or a person who is expected to take the drug\n* Clinical trial drugs, barbiturates, etc. within 1 month before the first scheduled administration date. People who have taken drugs that induce drug-metabolizing enzymes or inhibit drug-metabolizing enzymes such as clarithromycin\n* Those who consumed grapefruit-containing foods such as grapefruit (grapefruit) or grapefruit juice from 3 days before the first scheduled administration of the investigational drug until the last discharge, and those who cannot refrain from consuming foods containing grapefruit (grapefruit) during the above period\n* Those who have unusual eating habits (e.g. drinking more than 1L of grapefruit juice per day) or who are unable to consume the standardized diet provided by the clinical trial center during hospitalization\n* Smokers (However, if you quit smoking 3 months or more before the scheduled date of first administration of the investigational drug, you can be selected as a test subject)\n* Those who continuously drink alcohol (exceeding 21 units\u002Fweek, 1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking from 3 days before the first scheduled administration of the investigational drug until the last discharge\n* Continuously consumed excessive caffeine (more than 5 units\u002Fday) or consumed caffeine-containing foods (coffee, tea (black tea, green tea, etc.), carbonated beverages, coffee milk, nutritional supplements) during the period from 3 days before the first scheduled administration of the investigational drug until the last discharge. Those who cannot refrain from consuming tonic drinks, sports drinks, etc\n* A person who received an investigational drug by participating in another clinical trial (including a bioequivalence test) within 6 months before the scheduled date of first administration of the investigational drug\n* A person who has donated whole blood or component blood within 1 month within 2 months before the scheduled date of first administration of an investigational drug, or has received a blood transfusion\n* Those who are unable or unwilling to use a medically acceptable contraceptive method for themselves or their spouse (or partner) during the period before the clinical trial and at least 4 weeks after the last administration of the investigational drug, and those who do not agree not to donate sperm during that period\n* Other persons judged by the investigator to be unsuitable for participation in clinical trials",true,"MALE","19 Years","55 Years",{"count":615,"type":23},12,[54],"This clinical trial evaluated the safety, tolerability, pharmacokinetic properties, and immunogenicity of DNP007 when administered as a single dose. Since this is a phase 1 study for exploratory evaluation, to the extent that it meets the study objectives, In order to proceed with the minimum number of subjects, a total of 12 people, 3 for each dose group, was planned as the target number.",[619,29,620],"Liver Transplant Rejection","Steatohepatitis, Nonalcoholic","2024-06-13",{"date":623,"type":35},"2024-06-18",{"date":625,"type":35},"2024-06-10",{"date":627,"type":23},"2024-12-31",{"name":629,"class":42},"Seoul National University Hospital",{"id":631,"slug":632,"hasResults":12,"nctId":633,"briefTitle":634,"officialTitle":634,"acronym":4,"eligibilityCriteria":635,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":24,"phases":637,"briefSummary":638,"conditions":639,"keywords":641,"overallStatus":80,"whyStopped":4,"lastUpdateSubmitDate":647,"lastUpdatePostDateStruct":648,"startDateStruct":650,"completionDateStruct":651,"leadSponsor":653,"locationsCount":67},"100534264","impact-of-graft-reconditioning-with-hypothermic-machine-perfusion-on-hcc-recurrence-after-liver-transplantation-100534264","NCT06236568","Impact of Graft Reconditioning With Hypothermic Machine Perfusion on HCC Recurrence After Liver Transplantation","Inclusion Criteria:\n\n* Patients with HCC within Milan criteria at listing candidate for liver transplantation\n* ECOG 0-2\n* DBD donors\n* capability to sign an informed consent\n\nExclusion Criteria:\n\n* pediatric patients\n* DCD donors\n* DBD extended criteria requiring machine perfusion (no ethical randomization)\n* living donor liver transplantation\n* split liver",{"count":539,"type":23},[273],"The use of devices for liver grafts perfusion before transplantation, either hypothermic (HOPE) or normothermic (NMP), is rapidly spreading thanks to the promising results obtained so far in terms of graft survival and post-operative morbidity. Besides the well-established ability to increase the rate of transplantability of extended criteria donors (ECD) and donors after cardiac death (DCD), the use of machine perfusion (MP) may also improve the oncological outcomes of patients affected by hepatocellular carcinoma (HCC) undergoing liver transplantation (LT). The underlying mechanism is represented by the modulation of the ischemia-reperfusion injury (IRI)-related cellular damage obtained by the liver graft perfusion with HOPE before LT. The identification of biomarkers able to predict graft outcomes and highlight the mechanism of graft injury before transplantation rapidly and in non-invasive manner is therefore needed. Mass spectrometry-based metabolomics has already shown its potential by using perfusion liquids or pre-implantation biopsies.\n\nThe aim of the investigators is to run an open-label, randomised, controlled trial to study the impact of treating standard liver grafts from brain dead donors (DBD) with HOPE before liver transplant in patients affected by HCC. Patients aged 18-75 years presenting with HCC Milan-in at listing will be considered for inclusion. Presence of extra-hepatic disease and general contraindications to liver transplantation as defined by the local tumor board are considered as exclusion criteria. Eligible patients will be randomly assigned (1:1) with the use of a dedicated software to MP (intervention group) or no-MP (control group) before liver transplantation. Untargeted mass spectrometry metabolomics (UHPLC-HRMS) will be performed on liver graft perfusate, liver graft biopsy and recipient blood samples, to identify by classification methods, novel predictive markers of IRI. Furthermore, rapid targeted MS approaches will be performed on VIP metabolites and known key compounds (such as TCA, aminoacids, energy metabolism) to rapidly assess graft function as well as post-operative outcome.\n\nBlood samples of the recipient will be collected at two checkpoints (listing, and 3 months after liver transplant) to evaluate exosomes and miRNA expression fluctuations (liquid biopsy).\n\nPrimary outcomes of the study will be overall survival, graft survival and recurrence-free survival at 1- and 2-years. Survival results will be compared to those expected based on the Metroticket 2.0 score to assess the impact of MP in reducing the risk of HCC recurrence. Patients will remain in follow-up as for clinical practice to assess 3- and 5-years survival. Secondary end-point will be to define liquid biopsy efficacy to predict HCC recurrence and to define the correlation between metabolomic observations and HCC recurrence pattern.",[640,29],"Hepatocellular Carcinoma",[642,350,643,644,645,646],"Hepatocellular carcinoma","Metabolomics","Liquid biopsy","Machine perfusion","Ischemia reperfusion injury","2024-02-06",{"date":649,"type":35},"2024-02-07",{"date":647,"type":35},{"date":652,"type":23},"2030-12-31",{"name":654,"class":42},"Azienda Ospedaliero-Universitaria di Modena"]