[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"liver-transplant\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:liver-transplant":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,46,85,112,143,169,190,217,243,273,296,326,347,389,410,432,458,478,505,553,576,603,631,655,676],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100521911","phase-2-cytomegalovirus-cmv-vaccine-in-orthotopic-liver-transplant-candidates-100521911",false,"NCT06075745","Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates","Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates (CTOT-44)","COLT","Inclusion Criteria:\n\n1. Subject must be able to understand and provide informed consent\n2. Negative for Cytomegalovirus (CMV) IgG antibody as assessed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory within 12 months of enrollment, and no history of prior positive CMV serology (IgG antibody)\n3. Negative human immunodeficiency virus (HIV) testing and no clinical suspicion of HIV infection\n4. Planned for a first living donor liver transplant or listed\u002Fanticipated to be listed for a first deceased donor liver transplant.\n5. Anticipated to receive a liver transplant within 1-12 months\n6. For individuals of reproductive potential, a negative serum or urine pregnancy test within 72 hours prior to enrollment. NOTE: Individuals of reproductive potential are defined as individuals who have reached menarche and who have not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) \\>=40 IU\u002FmL or 24 consecutive months if an FSH is not available, i.e., who have had menses within the preceding 24 months, and have not undergone a sterilization procedure (e.g., hysterectomy, bilateral oophorectomy, or salpingectomy)\n7. Participants who are able to impregnate or become pregnant (i.e., of reproductive potential) and are participating in sexual activity that could lead to pregnancy must agree to practice contraception\u002Fbirth control (hormonal or barrier method) or agree to not participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) for at least 1 month following the last vaccine\u002Fplacebo dose. For acceptable contraception methods that are more than 80 percent effective, see Food and Drug Administration (FDA) Office of Women's Health (http:\u002F\u002Fwww.fda.gov\u002Fbirthcontrol)\n8. The most recent platelet count is \\>= 20,000 cells\u002Fmm\\^3 within 3 months prior to enrollment and in the opinion of the investigator, has not decreased \\\u003C 20,000 cells\u002Fmm\\^3 at time of study IP administration.\n\nEligibility criteria required: Dose 2:\n\n1. Most recent platelet count \\>= 20,000 cells\u002Fmm\\^3 within 3 months prior to enrollment and in the opinion of the investigator, has not decreased \\\u003C 20,000 cells\u002Fmm\\^3 since last result\n2. For women of reproductive potential as defined previously, a negative serum or urine pregnancy test (performed within 72 hours)\n\nExclusion Criteria:\n\n1. Women who are breastfeeding or planning to breastfeed\n2. Prior Cytomegalovirus (CMV) vaccination\n3. Receipt of immunoglobulin or CMV-specific immunoglobulin within the last 3 months (this includes coronavirus disease (COVID) convalescent plasma)\n4. Currently enrolled in another interventional study that, in the investigator's opinion, could affect the evaluation of safety and\u002For vaccine effect outcomes\n5. Prior (ever) receipt of a stem cell transplant (Peripheral blood stem cell (PBSC), marrow, cord blood, etc.)\n6. Receipt of immunosuppression:\n\n   * Within the last 3 months prior to randomization:\n\n     * Systemic Chemotherapy or immunotherapy for cancer in the last 3 months (localized therapy for hepatocellular carcinoma \\[HCC\\] such as chemoembolization, Y-90 are not considered \"systemic chemotherapy\" and are not excluded)\n     * Systemic immunosuppressive agents (e.g., cyclophosphamide, methotrexate, mycophenolate, azathioprine, calcineurin inhibitors, mTOR inhibitors, TNF-alpha inhibitors) and\u002For combination immunosuppressive drugs for any autoimmune or other conditions in the last 3 months except corticosteroids as below\n   * Within the last 28 days prior to randomization: averaged daily corticosteroid therapy dose ≥20 mg of prednisone equivalent\n   * Within the last 6 months prior to randomization: receipt of T- or Bcell depleting agents (e.g. ATG, Alemtuzumab, Rituximab)\n7. Transplant status 1A or in the opinion of the investigator is likely to receive a transplant within the next month\n8. At the time of randomization, either listed for, or, in the opinion of the investigator, likely to receive any non-liver organ transplant\n9. Receipt of a clinical vaccine \\\u003C 14 days before or planned to receive a clinical vaccine \\\u003C14 days after the study agent\n10. Known allergy to any component of the study agent\n11. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study\n\nExclusion criteria required: Dose 2:\n\n1. Anaphylaxis or other severe reaction (Grade 4) considered definitely or probably attributable to dose 1\n2. Receipt of liver transplant prior to dose 2\n3. The participant must not have any severe acute illness or other factor, that, in the opinion of the investigator, requires postponement of dose 2 because of safety concerns. The participant can be re-evaluated for eligibility throughout the window of eligibility for the dose 2, once the illness or other factor has improved or resolved\n4. Receipt of a clinical vaccine \\\u003C 14 days before or planned to receive a clinical vaccine \\\u003C14 days after the study agent","ALL","18 Years",{"count":21,"type":22},416,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a multi-center clinical trial in Cytomegalovirus (CMV) seronegative prospective liver transplant recipients to determine the efficacy of two doses of Cytomegalovirus-Modified Vaccinia Ankara (CMV-MVA) Triplex CMV vaccine pre-transplant. The primary objective is to assess the effect of pre-transplant (Tx) Triplex vaccination on duration of CMV antiviral therapy (AVT) within the first 100 days post-Tx in CMV seropositive donor (D+) and seronegative (R-) (D+R-) liver transplant recipients (LTxRs). A protocol-mandated preemptive therapy (PET) will be used for CMV disease prevention in D+R- LTxRs.",[28],"Liver Transplant",[30,31,32],"Cytomegalovirus","Vaccine","Orthotopic Liver Transplant","RECRUITING","2026-06-30",{"date":36,"type":37},"2026-07-02","ACTUAL",{"date":39,"type":37},"2024-03-05",{"date":41,"type":22},"2028-02-28",{"name":43,"class":44},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",18,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100641683","impact-of-culture-of-perfusion-fluid-on-donor-derived-infection-management-and-outcome-in-liver-and-kidney-transplant-100641683","NCT07651137","Impact of Culture of Perfusion Fluid on Donor-derived Infection Management and Outcome in Liver and Kidney Transplant","PREVENT","Inclusion Criteria:\n\n* Adult patients (≥18 years old) undergoing liver or kidney transplantation at IRCCS AOUBO clinical center during the specified study periods\n* Availability of graft preservation fluid culture results\n* Signed informed consent\n\nExclusion Criteria:\n\n* None",{"count":54,"type":22},1400,"OBSERVATIONAL","This study aims to evaluate whether microbiological testing of the perfusion fluid used to transport transplanted organs can help predict the development of infections in liver and kidney transplant recipients, including possible donor-derived infections (infections transmitted from the donor organ).\n\nThe study will include all liver and kidney transplant recipients with available perfusion fluid culture results from 2021 until the start of the study (retrospective phase) and for two years after study initiation (prospective phase).\n\nThe study will assess how often high-risk microorganisms are identified in perfusion fluid, whether these findings are associated with complications or infections in recipients, and whether they affect patient outcomes, including mortality.",[58,59,28,60,61,62],"Liver Transplant Infection","Kidney Transplant Infection","Kidney Transplant","Bacterial Infection","Donor-derived Infection",[64,65,66,67,68,69,70,71,72],"perfusion fluid","graft","transplantation","transplant recipients","infections","donor-derived infections","liver transplant","kidney transplant","preservation fluid","NOT_YET_RECRUITING","2026-06-11",{"date":76,"type":37},"2026-06-16",{"date":78,"type":22},"2026-09-01",{"date":80,"type":22},"2029-08-31",{"name":82,"class":83},"IRCCS Azienda Ospedaliero-Universitaria di Bologna","OTHER",1,{"id":86,"slug":87,"hasResults":12,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":12,"sex":18,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":97,"briefSummary":98,"conditions":99,"keywords":100,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},"100635193","phase-2-early-signals-of-the-transition-from-immune-quiescence-to-activation-in-the-liver-allograft-microenvironment-and-in-the-circulation-100635193","NCT07549503","Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation","Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation (RTB-018)","iSYNAPSE","Inclusion Criteria:\n\n1. Participant and parent or guardian must be able to understand and provide informed assent and consent, respectively\n2. Recipient of a living or deceased donor Liver transplant (LTx) at \\\u003C7 years of age\n3. \\> 3 years but \\\u003C7 years after LTx at the time of study enrollment\n4. Stable liver tests defined as baseline serum alanine aminotransferase (ALT) level \\\u003C 30 IU\u002Fl and gamma-glutamyl transferase (GGT) level \\\u003C 50 IU\u002Fl (based on the average of the 3 most recent values prior to screening; all must be within 1 year of screening; 2 must be within 6 months of screening)\n5. No Acute rejection (AR) or chronic rejection within 12 months of enrollment\n6. Tacrolimus monotherapy for \\> 6 months with baseline 12-hour trough levels \\\u003C8 ng\u002FmL (based on the average of 3 values prior to screening; all must be within 1 year of screening; 2 must be within 6 months of screening)\n7. Participants of childbearing potential must have a negative pregnancy test upon study entry\n\nExclusion Criteria:\n\n1. Liver transplant (LTx) for autoimmune disease, including autoimmune hepatitis or primary sclerosing cholangitis\n2. LTx for hepatitis B or hepatitis C\n3. Recipient of any other organ transplant or liver re-transplant, except for patients who have a repeat LTx within 30 days of first LTx who are eligible for enrollment\n4. \\>=50 percent dose increase in tacrolimus within 12 months of enrollment\n5. Discontinued a second Immunosuppression (IS) agent within 12 months of enrollment\n6. Systemic illness requiring chronic or recurrent use of IS for which there is a risk of reactivation if tacrolimus is reduced\n7. Use of medication to treat systemic conditions which in the judgement of the investigator could influence results of the study\n8. Active or chronic infection requiring treatment\n9. Inability or unwillingness to comply with the study protocol\n10. Use of investigational drug within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of enrollment\n11. Has any condition that, in the opinion of the investigator, will interfere with safe participation in the trial","3 Years","13 Years",{"count":96,"type":22},100,[25],"This is a prospective multi-center, longitudinal study to determine efficacy of 50 percent Immunosuppression (IS) reduction. One hundred fully eligible participants will reduce IS by 50 percent in two steps. Liver tests will be checked every 0.5 months through month 4, once a month through month 12, and every other month through month 18. Liver transplant (LTx) center visits will take place at screening, months 6, 12 and 18 after initiating IS dose reduction. A protocol driven liver biopsy to adjudicate the endpoint will be performed at 18 months. The duration of the study from time of starting IS dose reduction to the primary endpoint assessment is 18 months.\n\nThe primary objective is to assess the efficacy of 50 percent IS dose reduction in children with Liver transplants (LTxs)",[28],[101,102],"Liver transplant","Immunosuppression","2026-06-05",{"date":105,"type":37},"2026-06-09",{"date":107,"type":37},"2026-05-14",{"date":109,"type":22},"2031-10-01",{"name":43,"class":44},10,{"id":113,"slug":114,"hasResults":12,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":123,"conditions":124,"keywords":128,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":84},"100632851","effect-of-preoperative-oral-carbohydrate-loading-on-postoperative-outcomes-in-liver-transplant-patients-100632851","NCT07519057","Effect of Preoperative Oral Carbohydrate Loading on Postoperative Outcomes in Liver Transplant Patients","Effect of Preoperative Oral Carbohydrate Loading on Postoperative Outcomes in Liver Transplant Patients: A Randomized, Placebo-Controlled Trial","Inclusion Criteria:\n\n* age ≥ 18 years\n* elective liver transplantation at the Department of General, Transplant, and Liver Surgery, Medical University of Warsaw\n* grafts from brain-dead donors\n* MELD score \\\u003C35\n\nExclusion Criteria:\n\n* acute liver failure\n* insulin-dependent diabetes mellitus\n* gastroparesis\n* mechanical bowel obstruction\n* liver retransplantation within less than 6 months of the primary transplant",{"count":120,"type":22},434,[122],"NA","The aim of the study is to evaluate the effect of preoperative oral carbohydrate loading on postoperative outcomes in liver transplant recipients. The results of this study may contribute to improving recovery after liver transplantation and shortening postoperative hospital stay in these patients.\n\nParticipants will be randomly assigned to either the study group or the control group. Patients assigned to the study group will receive 400 mL of a carbohydrate beverage (Nutricia preOp®), to be consumed up to 2 hours before the anesthesia induction. Patients assigned to the control group will receive 400 mL of a placebo administered in an identical manner as in the study group. Participants will not be informed which group they have been assigned to.\n\nIn the postoperative period, routine laboratory and imaging tests will be performed, and their results will be used to assess the effects of the intervention. Follow-up of the patient's clinical course is planned for up to 30 days after surgery. The schedule of follow-up visits will not differ from standard clinical practice.",[125,28,126,127],"Liver Transplantation","Liver Transplant Surgery","End Stage Liver Disease",[129,130,131,125,28,132,133],"Preoperative Oral Carbohydrate Loading","POCL","Nutricia PreOp","Carbohydrate drink","Preoperative Carbohydrate Loading","2026-06-01",{"date":136,"type":37},"2026-06-03",{"date":138,"type":37},"2026-05-27",{"date":140,"type":22},"2028-08",{"name":142,"class":83},"Medical University of Warsaw",{"id":144,"slug":145,"hasResults":12,"nctId":146,"briefTitle":147,"officialTitle":148,"acronym":149,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":23,"phases":153,"briefSummary":154,"conditions":155,"keywords":156,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},"100537678","phase-2-expanding-liver-transplant-immunosuppression-minimization-via-everolimus-100537678","NCT06280950","Expanding Liver Transplant Immunosuppression Minimization Via Everolimus","Expanding Liver Transplant Immunosuppression Minimization Via Everolimus (CTOT-43)","ELIMINATE","Inclusion Criteria:\n\n1. Subject and\u002For legal guardian must be able to understand and provide informed consent\n2. Adult (age greater than or equal to 18 years of age at time of informed consent) recipient of first liver transplant alone (de novo)\n3. Estimated glomerular filtration rate \\>=30 ml\u002Fmin\u002F1.73m\\^2 at enrollment using the CKD-EPI 2021 equation\n4. Treatment with tacrolimus therapy, with or without mycophenolic acid derivatives and\u002For corticosteroids\n5. Female subjects of childbearing potential with negative pregnancy test upon study entry\n6. All subjects of reproductive potential agreeing to use contraception for the duration of the study\n7. Previous vaccination or documented immunity to varicella, measles, hepatitis B, pneumococcus, influenza, zoster (if \\>=19 years old), and 2019-nCoV (COVID-19) as outlined in the DAIT Vaccination Guideline\n\nExclusion Criteria:\n\n1. Inability or unwillingness of a participant to give written informed consent or comply with study protocol\n2. Active unresolved systemic viral, bacterial, fungal, or parasitic infection requiring oral or intravenous anti-infective therapy\n3. History of autoimmune liver disease including autoimmune hepatitis, primary sclerosing cholangitis, and\u002For primary biliary cirrhosis, or other contraindications to drug withdrawal\n4. History of non-hepatic autoimmune disease requiring current or future systemic immunosuppressive therapy other than per study protocol\n5. History post-transplant of Hepatic Artery Thrombosis or Portal Vein Thrombosis.\n6. History of recurrent cirrhosis after liver transplantation.\n7. Chronic use of systemic glucocorticoids, biological immunomodulatory therapy, or other immunosuppressive agents other than per study protocol\n8. History of hepatitis B or C virus infection with detectable viral PCR at enrollment\n9. History of prior organ transplantation (liver or other type)\n10. History of \\>= 2 biopsy-proven acute cellular rejection episodes of any severity, \\>=1 moderate to severe rejection episode (histologically defined or requiring lymphodepletion therapy), or \\>= 1 antibody- mediated rejection episode\n11. Active treatment with any mTOR-inhibitor agent (everolimus, sirolimus)\n12. Contraindication to treatment with everolimus (open wound or wound infection; urine protein: creatinine ratio \\> 0.5; significant pancytopenia (any of the following: WBC \\\u003C1.5 K\u002FuL or ANC \\\u003C1000 cells\u002FuL or actively being treated with GCSF; Hb \\\u003C8.0; platelet count \\\u003C50K); serum triglycerides \\> 1000 mg\u002FdL; other per PI)\n13. Abnormal liver function tests on study entry: Total Bilirubin (TB)\\>1.5 mg\u002FdL and Direct Bilirubin (DB) \\>1.0 mg\u002FdL, Alkaline Phosphatase (AP) \\>200 U\u002FL, and Alanine Aminotransaminase (ALT)\\>60 U\u002FL\n14. Pregnant on enrollment or plan to become pregnant during the study period\n15. Participation in another clinical trial that would interfere with this study's procedures and intervention:\n\n    1. Use of investigational biologic or drug (within 8 weeks of study enrollment)\n    2. Additional blood collection that would exceed research blood draw limits\n    3. Any other procedure or intervention, in the investigator's opinion would interfere with this study\n16. Received live attenuated vaccine(s) within 2 months of enrollment\n17. Current, diagnosed, mental illness or current, diagnosed, or self-reported drug or alcohol abuse that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study\n18. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.",{"count":152,"type":22},340,[25],"This is a study to determine the safety, efficacy, and tolerability of taking away the anti-rejection medicine, tacrolimus, in liver transplant recipients in conjunction with everolimus monotherapy to preserve renal function. Two hundred - seventy (270) subjects will be randomized 2:1 into one of two groups between 2-3 months post-transplant. Seventy participants will be placed into an observational group and will remain on their current post-transplant medications. The duration of the study from time of enrollment is 18-20 months.",[28],[157,158,159],"Liver","Transplant","Everolimus","2026-05-20",{"date":162,"type":37},"2026-05-22",{"date":164,"type":37},"2024-09-12",{"date":166,"type":22},"2030-06-30",{"name":43,"class":44},8,{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":173,"acronym":174,"eligibilityCriteria":175,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":178,"conditions":179,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":183,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":84},"100182092","proteogenomic-monitoring-and-assessment-of-liver-transplant-recipients-100182092","NCT01644903","Proteogenomic Monitoring and Assessment of Liver Transplant Recipients","\"Mini-Liver\"","Inclusion Criteria:\n\n1. Male and female recipients of all races, ≥18 years of age.\n2. Patients undergoing primary or subsequent living or deceased donor liver transplantation.\n3. Subject and\u002For guardian must be able to provide informed consent.\n4. Subject and\u002For guardian must be able to comply with the study protocol.\n\nExclusion Criteria:\n\n1\\. Inability or unwillingness of a participant and\u002For guardian to provide informed consent.",{"count":177,"type":22},1000,"This study is being done to test blood, urine and tissue samples to see if this can help decide if CKD (Chronic Kidney Disease), AR (Acute Rejection) and HCV (Hepatitis C Virus) can be identified in its early stages. CKD damage to the kidneys, AR and HCV all lower the body's ability to function properly. Early detection of these conditions could assist with successful treatment and possibly lead to less repeat organ transplants.",[28,180,181,182],"Hepatitis C","Chronic Kidney Disease","Acute Rejection",{"date":162,"type":37},{"date":185,"type":4},"2010-04",{"date":187,"type":22},"2031-12",{"name":189,"class":83},"Northwestern University",{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":84},"100638137","hypothermic-machine-perfusion-for-liver-graft-preservation-100638137","NCT07595627","Hypothermic Machine Perfusion for Liver Graft Preservation","Prospective and Randomized Clinical Study of the Effect of Hypothermic Machine Perfusion on Liver Graft Preservation","HOPE-Liver","Donor-related inclusion criteria:\n\n* Liver donors with confirmed diagnosis of brain death.\n* Extended criteria donors (ECD).\n* Age ≥18 years.\n* Family consent for organ donation obtained.\n* Negative serology for HTLV, HIV, Chagas disease, and hepatitis B and C.\n\nRecipient-related inclusion criteria:\n\n* Adult patients (≥18 years) undergoing liver transplantation.\n* Diagnosis of end-stage liver disease or indication for liver transplantation.\n* Candidates for primary liver transplantation.\n* Ability to understand and provide written informed consen\n\nDonor-related exclusion criteria:\n\n* Presence of moderate or severe hepatic steatosis.\n* Pediatric donors.\n* Donors classified as ideal, defined by the simultaneous presence of all of the following criteria: Age \\\u003C35 years, Body mass index (BMI) \\\u003C28 kg\u002Fm², No history of cardiopulmonary resuscitation, Norepinephrine requirement \\\u003C0.5 µg\u002Fkg\u002Fmin, Liver enzymes (AST or ALT) ≥2 times the upper limit of normal, Intensive care unit stay ≤7 days\n\nRecipient-related exclusion criteria:\n\n* Complex portal vein thrombosis (grade III or IV).\n* Combined or dual organ transplantation.\n* Retransplantation.\n* Acute liver failure.\n* MELD score \\>30.\n* History of multiple prior liver or biliary surgeries.",{"count":199,"type":22},40,[122],"The goal of this clinical trial is to evaluate whether hypothermic machine perfusion improves liver graft preservation and post-transplant outcomes compared to conventional static cold storage in adult patients undergoing liver transplantation. This study focuses on liver grafts from deceased donors, including those with extended criteria, which are more susceptible to ischemia-reperfusion injury and early graft dysfunction.\n\nThe main questions it aims to answer are:\n\nDoes hypothermic machine perfusion reduce ischemia-reperfusion injury and improve early graft function after liver transplantation? Does this preservation strategy improve clinical outcomes, including graft survival, complication rates, and post-transplant recovery, compared to static cold storage?\n\nResearchers will compare hypothermic machine perfusion (ex situ, oxygenated perfusion at low temperature) to standard static cold storage to assess differences in graft preservation quality and post-transplant outcomes.\n\nParticipants will:\n\nReceive a liver graft preserved either by hypothermic machine perfusion or static cold storage, according to a 1:1 randomization protocol Undergo standard liver transplantation procedures Be followed after transplantation with clinical, laboratory, imaging, and biomarker assessments at predefined time points (7 days, 30 days, 6 months, and 1 year)\n\nAdditional evaluations will include biochemical markers of liver function, inflammatory and immunological mediators, mitochondrial function assessment, and histological analysis to better characterize graft injury and recovery.",[28,203],"Liver Failure",[205,125,206,207,208],"Hypothermic Machine Perfusion","Ischemia-Reperfusion Injury","Ex Vivo Liver Perfusion","Extended Criteria Donors",{"date":210,"type":37},"2026-05-19",{"date":212,"type":22},"2026-05-07",{"date":214,"type":22},"2028-05-07",{"name":216,"class":83},"University of Sao Paulo General Hospital",{"id":218,"slug":219,"hasResults":12,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":23,"phases":227,"briefSummary":229,"conditions":230,"keywords":231,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":242},"100580045","phase-1-evr-and-epo-for-liver-transplant-tolerance-100580045","NCT06832189","EVR and EPO for Liver Transplant Tolerance","Everolimus and Epoetin for Sustained Liver Transplant Tolerance (EVEREST)(ITN101ST)","EVEREST","Inclusion Criteria:\n\n1. Subject must be able to understand and provide informed consent\n2. 1-10 years post-liver transplant\n3. Tacrolimus-containing maintenance immunosuppression (IS) regimen without corticosteroid. Mycophenolate mofetil (MMF) dose must be \\\u003C=2000 mg daily or mycophenolic acid (MPA) dose\\\u003C=1440 mg daily (if on MMF or MPA). Tacrolimus level must be \\\u003C8 ng\u002Fml on the 2 most recent laboratory results within 3 months.\n4. Gamma glutamyl transferase (GGT) and alanine transaminase (ALT) \\\u003C= upper limit of normal (ULN)\n5. Estimated glomerular filtration rate (GFR) \\>=40 mL\u002Fmin\u002F1.73 m\\^2 using the CKD-EPI 2021 equation\n6. Female subjects of reproductive potential must have a negative pregnancy test upon study entry\n7. Female subjects with reproductive potential, must agree to use Food and Drug Administration (FDA)-approved methods of birth control for the duration of the study\n8. Subjects must have current vaccinations or documented immunity as per the Division of Allergy, Immunology, and Transplantation (DAIT) vaccine guidance for subjects in transplant trials\n9. Negative result of most recent tuberculosis (TB) testing or appropriately completed latent tuberculosis infection (LTBI) therapy. Testing should be conducted using either a purified protein derivative (PPD) or interferon-gamma release assay (i.e., QuantiFERON-TB, T-SPOT.TB). Results from tests performed within 12 months prior to study entry are acceptable in the absence of any intervening exposure to TB. Subjects with a positive test for LTBI must complete appropriate therapy for LTBI. LTBI treatment regimens should be among those endorsed by the Centers for Disease Control and Prevention (CDC)\n10. Negative FDA-approved test for human immunodeficiency virus (HIV) diagnosis at screening or as documented in medical record, up to 12 months prior to screening)\n11. Negative hepatitis C antibody test at screening or as documented in medical record, up to 12 months prior to screening, in subjects without a history of hepatitis C. If there is a history of treated hepatitis C, then documentation of two consecutive negative hepatitis C virus (HCV) quantitative RNA polymerase chain reaction (PCR) tests separated by at least 3 months is required. Untreated subjects with positive HCV antibody and a single negative quantitative HCV RNA are eligible. Historical negative HCV RNA results are acceptable in the above two cases with positive HCV antibody\n12. Negative hepatitis B surface antigen and negative hepatitis B core antibody in subjects without a history of hepatitis B virus (HBV) infection, up to 12 months prior to screening. Those with known hepatitis B infection or positive hepatitis B surface antigen or positive hepatitis B core antibody must be on antiviral therapy and have negative HBV DNA quantitative PCR at screening\n\nExclusion Criteria:\n\n1. Inability of a subject to comply with study protocol\n2. Any medical condition requiring chronic systemic corticosteroid, e.g., severe reactive airways disease. Use of inhaled steroids is not an exclusion\n3. Autoimmune cause of liver disease (including autoimmune hepatitis (AIH), primary sclerosing cholangitis, primary biliary cirrhosis)\n4. Diagnosis of rejection within 52 weeks prior to screening\n5. Donor human leukocyte antigen (HLA) typing unavailable or inadequate for assigning donor-specific antibody (DSA)\n6. Need for uninterrupted anticoagulation\n7. Known active current or history of invasive fungal infection, or mycobacterial infection within 1 year prior to screening\n8. Human immunodeficiency virus (HIV)-positive\n9. Serious uncontrolled concomitant major organ disease\n10. Recipient of non-liver solid organ or bone marrow transplant\n11. Any infection requiring hospitalization and IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks\n12. Malignancy within the last 5 years except treated basal and squamous cell cancer of the skin or treated in situ cervical cancer. History of hepatocellular carcinoma in the explanted liver is acceptable provided that\n\n    1. the last alpha fetoprotein obtained within 3 months prior to liver transplantation was \\\u003C 400 microg\u002FL, and\n    2. the recipients' explanted liver did not have evidence of increased risk of recurrent cancer, i.e., explant was within the Milan criteria, with no vascular invasion, and with no cholangiocarcinoma morphology\n13. Neutropenia (absolute neutrophil count or ANC \\\u003C1000 microliter) within 4 weeks prior to study enrollment\n14. History of hypersensitivity to Epoetin (EPO) or mammalian Target of Rapamycin inhibitor (mTOR-I)\n15. History of angioedema\n16. History of hereditary disorders of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. History of lactose intolerance is not an exclusion\n17. History of genetic disorders predisposing to thrombosis including but not limited to Factor V Leiden mutation, prothrombin 20210, protein C deficiency, protein S deficiency, antithrombin III deficiency\n18. History of venous or arterial thrombosis or thromboembolism, acute MI, or thrombotic stroke except for a history of isolated portal vein thrombosis in the setting of hepatic cirrhosis\n19. History of Budd Chiari syndrome\n20. Hemoglobin \\> 13.5 g\u002Fdl\n21. Plasma fibrinogen or D-dimer level \\> ULN\n22. Planned major surgery within the next 12 months\n23. Uncontrolled severe hypertension\n24. Uncontrolled clinically significant cardiac arrhythmia\n25. Proteinuria with urine protein\u002Fcreatinine \\>0.5 g\u002Fg\n26. Severe hyperlipidemia with total cholesterol \\>350 mg\u002Fdl or triglycerides \\>1000 mg\u002Fdl\n27. Current alcohol, drug, or chemical dependency\n28. Currently pregnant or nursing\n29. Current treatment with an estrogen-containing oral contraceptive, or systemic estrogen replacement therapy\n30. Treatment with an immunomodulatory biological drug within 12 weeks of study entry\n31. Immunization with live vaccine within 2 weeks of study baseline visit\n32. Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of screening\n33. Past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the subject's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study",{"count":226,"type":22},20,[228],"PHASE1","This is an open label, single-arm, multicenter phase 1b study of stable adult liver transplant recipients on a tacrolimus (TAC)-based immunosuppression (IS) regimen who will transition from TAC to Everolimus (EVR), receive five doses of EPO and concurrently initiate phased withdrawal from EVR.\n\nThe primary objective is to test the safety of administering Everolimus (EVR) and epoetin alfa (EPO) to induce operational tolerance in stable adult liver transplant recipients",[28],[159,28,232,233],"Epoetin alfa","Tacrolimus","2026-04-03",{"date":236,"type":37},"2026-04-06",{"date":238,"type":37},"2026-01-21",{"date":240,"type":22},"2030-06-01",{"name":43,"class":44},3,{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":23,"phases":253,"briefSummary":254,"conditions":255,"keywords":258,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":111},"100535624","phase-2-safety-of-atezolizumab-bevacizumab-in-liver-transplanted-patients-with-advanced-hepatocellular-carcinoma-100535624","NCT06254248","Safety of Atezolizumab-Bevacizumab in Liver Transplanted Patients With Advanced Hepatocellular Carcinoma","IMMUNO-TH","Inclusion Criteria:\n\n* All patients over 18 and under 90 years old:\n* who underwent LT more than 6 months ago (to prevent the higher risk of ACR which exists within the first months after LT and to deal with populations with a lowered immunosuppressive regimen long after LT)\n* with HCC recurrence diagnosis according to the EASL diagnostic criteria (33)\n* with advanced HCC not accessible to surgery and locoregional treatment\n* with at least one measurable untreated lesion\n* With a proposal for Atezo-Beva in first line treatment made in a multidisciplinary meeting\n* Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment, unless otherwise specified:\n\n  * ANC ≥ 1.5 x 109\u002FL (1500\u002FµL) without granulocyte colony-stimulating factor support\n  * Lymphocyte count ≥ 0.5 x 109\u002FL (500\u002FµL)\n  * Platelet count ≥ 75 x 109\u002FL (75,000\u002FµL) without transfusion\n  * Hemoglobin ≥ 90 g\u002FL (9 g\u002FdL). Patients may be transfused to meet this criterion.\n  * AST, ALT ≤ 5 x upper limit of normal (ULN)\n  * Serum bilirubin ≤ 3x ULN\n  * creatinine clearance≥40 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n  * For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 2x ULN\n  * Urine dipstick for proteinuria \\\u003C 2+ (within 7 days prior to initiation of study treatment). Patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24-hour urine collection and must demonstrate \\\u003C1 g of protein in 24 hours\n* ECOG Performance Status of 0 or 1\n* For women of childbearing potential and men: agreement to remain abstinent or use effective contraception during treatment and at least :\n\n  * 5 months after the end of the treatment with atezolizumab,\n  * 6 months after the end of the treatment with bevacizumab\n* Child-Pugh class A\n\nExclusion Criteria:\n\n* History of ACR within 3 months before starting Atezo-Beva treatment\n* Banff score for ACR ≥ 3 on liver biopsy performed before the initiation of the treatment\n* Pregnant or breastfeeding woman\n* Patient not affiliated to a beneficiary or entitled social security scheme or to the PUMA\n* Patient not having signed consent\n* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT-scan\n* History of malignancy other than HCC within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death\n* Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or high-risk for bleeding\n* A prior bleeding event due to esophageal and\u002For gastric varices within 6 months prior to initiation of study treatment.\n* Inadequately controlled arterial hypertension (defined as systolic blood pressure (BP) ≥ 160 mmHg and\u002For diastolic blood pressure \\> 100 mmHg), based on an average of ≥ 3 BP readings on ≥ 2 sessions Anti-hypertensive therapy to achieve these parameters is allowable.\n* Prior history of hypertensive crisis or hypertensive encephalopathy\n* History of intestinal obstruction and\u002For clinical signs or symptoms of GI obstruction including sub-occlusive disease related to the underlying disease or requirement for routine parenteral hydration\n* Serious, non-healing or dehiscing wound, active ulcer, or untreated bone fracture\n* Metastatic disease that involves major airways or blood vessels, or centrally located mediastinal tumor masses\n* Hypersensitivity to the active substance or to any of the excipients of the SmPC of bevacizumab and the SmPC of atezolizumab\n* Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant human or humanised antibodies\n* Prior arterial thromboembolic reactions including cerebrovascular accidents, transient ischaemic attacks and myocardial infarctions;\n* Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina\n* In case of proteinuria \\> 1g in 24 hours\n* History of leptomeningeal disease\n* Active tuberculosis\n* Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia","90 Years",{"count":252,"type":22},50,[25],"The prognosis of liver transplanted (LT) patients with recurrence of hepatocellular carcinoma (HCC), especially those with progression after locoregional treatment or advanced HCC, remains poor. Current treatment modalities involve tyrosine kinase inhibitors (TKIs) characterized by a low response rate and often poor tolerability. Encouraging findings from the Imbrave 150 study, demonstrating increased survival rates coupled with favorable treatment tolerance, prompt the investigators to consider the potential of offering the combination of treatment with Atezolizumab-Bevacizumab (Atezo-Beva) to patients with LT. No data regarding the safety and efficacy of this new combination are available for patients with LT as they were not included in Imbrave 150. Immunosuppression after LT is low when compared to essentially all other organ recipients, liver recipients are considered with lower immunological risk. However, the use of ICIs has been associated with a risk of hepatic rejection in LT patients. In this study, in order to prevent acute cellular rejection (ACR) occurrence, we propose to adopt a standardized immunosuppressive regimen closed to the one used immediately after LT but with lower therapeutic goals for tacrolimus and everolimus to allow immunotherapy treatment to be effective. The better tolerance of liver grafts will probably lead to less risk of rejection with Atezo-Beva than in other organ transplants.",[28,256,257],"Hepatocellular Carcinoma Recurrent","Systemic Treatment",[259,260,261,262,263],"HCC","systemic therapy","graft rejection","immunotherapy","Atezolizumab-Bevacizumab","2026-03-06",{"date":266,"type":37},"2026-03-10",{"date":268,"type":37},"2026-01-22",{"date":270,"type":22},"2030-01-01",{"name":272,"class":83},"Assistance Publique - Hôpitaux de Paris",{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":279,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":281,"maxAge":282,"enrollmentInfo":283,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":285,"conditions":286,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":84},"100542414","transitional-epro-diary-liver-transitional-epro-100542414","NCT06342557","Transitional ePRO Diary Liver (Transitional-ePRO)","Integrated System for Patients Who Belong the Transition to Adult Services and Are Undergoing a Liver Transplant","MACROLIVER","Inclusion Criteria:\n\n* patients between the ages of 14 and 20 who have been transplanted at the ASST-PG23 transplant center or are awaiting a liver transplant and belong to the transition to adult services\n* signed informed consent\n* proven use of the APPs (to be assessed based on the last 2 weeks)\n\nExclusion Criteria:\n\n\\-","14 Years","20 Years",{"count":284,"type":22},250,"The study is part of the MACROLIVER Project, whose main objective is to create a digital tool for patients and caregivers for the management of liver disease that allows the optimization of therapy and\u002For the treatment process, even remotely. Such a tool not only reduces the movement of patients who are by definition fragile, but also enables the optimization of access and care by a multidisciplinary team. This tool is intended to support doctors and patients, but in no way replaces normal clinical practice. This study aims to explore the specificities of patients experiencing the transition from the pediatric ward to the adult ward in order to identify risk and protective factors that influence psychological well-being at both an individual and relational level. In order to gather all the information about the patients attending the transitional clinic and to obtain a more complete and truthful clinical-psychological picture, the study also includes the collection of retrospective data of the transplanted patients.",[28],"2026-02-24",{"date":289,"type":37},"2026-02-27",{"date":291,"type":37},"2024-03-28",{"date":293,"type":22},"2034-02-21",{"name":295,"class":83},"FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS",{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":300,"acronym":4,"eligibilityCriteria":301,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":23,"phases":304,"briefSummary":305,"conditions":306,"keywords":309,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":317,"lastUpdatePostDateStruct":318,"startDateStruct":320,"completionDateStruct":322,"leadSponsor":324,"locationsCount":84},"100616061","renal-histopathology-and-transcriptomic-analysis-in-hepatorenal-syndrome-during-liver-transplantation-100616061","NCT07300709","Renal Histopathology and Transcriptomic Analysis in Hepatorenal Syndrome During Liver Transplantation","Inclusion Criteria:\n\n1. Patient must be able to understand and provide informed consent\n2. Age ≥ 18 years of age at time of study entry\n3. Accepted for liver transplantation (LT)\n4. Fulfill the diagnostic criteria of HRS AKI according to International Club of Ascites (ICA) guidelines\n\n3-month post transplant renal biopsy inclusion criteria:\n\n1. Patient with adequate intraoperative renal biopsy\n2. Patient must be able to understand and provide informed consent\n\nExclusion Criteria:\n\n1. Inability or unwillingness to give written informed consent\n2. Patient with known pre-existing renal disease\n3. Patient with solitary kidney\n4. Re-transplantation\n5. ABO-incompatible LT\n6. Fail to provide 3-month post transplant renal biopsy\n\n3-month post transplant renal biopsy exclusion criteria:\n\n1. Graft failure after LT\n2. Any condition deemed inappropriate by the PI",{"count":303,"type":22},42,[122],"Hepatorenal Syndrome (HRS) is a serious complication that can occur in patients with liver cirrhosis, characterised by kidney dysfunction, or acute kidney failure (AKI). While it has traditionally been thought that HRS affects structurally normal kidneys and is completely reversible with liver transplantation, recent evidence suggests this may not always be the case.\n\nThe purpose of this study is to examine the actual structural changes in the kidneys of patients with HRS through tissue biopsy and advanced molecular analysis. This may help us better understand the disease mechanism and potentially improve treatment approaches. We aim to challenge the current understanding that HRS always occurs in structurally normal kidneys and is always reversible after liver transplantation. This study will provide valuable insights into the pathophysiology of HRS and may lead to improved diagnostic and treatment strategies in the future.\n\nThis is a 3-year single center prospective, non-randomised, open label study at Queen Mary Hospital, The University of Hong Kong. All consecutive patients accepted on the liver transplant waiting list will be invited to participate. Patient will undergo several procedures related to liver transplant and kidney assessment, and receive liver transplantation and renal biopsy.",[307,308,28],"Hepatorenal Syndrome, Liver Regeneration","AKI - Acute Kidney Injury",[310,311,312,313,70,314,315,316],"Hepatorenal syndrome","HRS","HRS AKI","acute kidney injury","renal biopsy","renal histopathology","transcriptomics","2025-12-17",{"date":319,"type":37},"2025-12-24",{"date":321,"type":22},"2026-01-01",{"date":323,"type":22},"2028-12",{"name":325,"class":83},"The University of Hong Kong",{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":12,"sex":18,"minAge":333,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":339,"lastUpdatePostDateStruct":340,"startDateStruct":342,"completionDateStruct":344,"leadSponsor":346,"locationsCount":84},"100616392","feasibility-and-acceptability-of-a-new-tool-promoting-a-healthy-lifestyle-in-liver-and-kidney-transplant-recipients-100616392","NCT07305012","Feasibility and Acceptability of a New Tool Promoting a Healthy Lifestyle in Liver and Kidney Transplant Recipients","Feasibility and Acceptability of a New Tool for a Conscious Education and Motivation Promoting a hEalthy LIfestyle in Liver and Kidney Transplant rEcipients","Inclusion Criteria:\n\n* Age ≥ 60 years\n* Liver or kidney transplant received at least 6 months and no more than 25 years prior\n* BMI between 21 and 29.9\n* Signed informed consent\n* Having a personal smartphone\n* Stable immunosuppressive therapy in the past 3 months\n\nExclusion Criteria:\n\n* Significant weight change (\\>5% of body weight) in the past 3 months\n* Combined liver-kidney transplant\n* Medical conditions requiring specific diets that may render adherence to the dietary recommendations of the trial unsafe (e.g., chronic kidney disease, inflammatory bowel disease, celiac disease, bariatric surgery, etc.)\n* General physical conditions deemed by the investigator to contraindicate safe participation in any of the trial activities (e.g., blindness, vertebral fractures, wheelchair dependence, home oxygen therapy, etc.)\n* Adherence to specific dietary regimens for ethical and\u002For religious reasons that are incompatible with the dietary recommendations of this trial\n* Active malignant tumors currently under pharmacological treatment or awaiting surgical treatment (except cutaneous squamous cell carcinomas), or history of malignant tumors within the last 5 years, except for hepatocellular carcinoma\n* Psychiatric comorbidities deemed by the investigator to potentially compromise safety and\u002For adherence, thereby risking biasing the results (e.g., schizophrenia, bipolar disorder, eating disorders, etc.)\n* Changes in glucose-lowering or lipid-lowering therapy during the 90 days prior to the enrollment visit\n* Active participation in another research or non-research program aimed at lifestyle modification\n* Any clinical condition, diagnosed or under diagnostic evaluation, that the investigator considers may compromise safety and\u002For a priori adherence to the intervention, with a potential risk of altering the study outcomes","60 Years",{"count":335,"type":22},60,[122],"This interventional clinical trial tests whether a doctor-delivered lifestyle counseling program, supported by two personalized digital tools, is feasible and helpful for improving healthy eating and physical activity in older adults (65 years or older) who previously received a liver or kidney transplant.\n\nAll participants first receive medical counseling on healthy diet and physical activity. After 12 weeks, they begin using two smartphone apps (\"Gamebus\" and \"Nutrida\") designed to support behavior change at home. Each participant acts as their own comparison, and results after starting the apps are compared with their own results before using them.\n\nThe main goal is to find out whether participants can safely use the apps and follow the program (for example: staying in the study, using the apps daily, completing weekly tasks). The study also looks at whether the combined approach-counseling plus digital support-can help improve eating habits, physical activity, body measurements, and routine lab values related to metabolic health.\n\nParticipants attend three study visits over 24 weeks. At each visit, they complete questionnaires, undergo body measurements and body composition tests, review their recent diet, and receive lifestyle guidance. At the end, the study will help determine whether this digital-supported lifestyle program is practical and acceptable for older transplant recipients.",[28,60],"2025-12-12",{"date":341,"type":37},"2025-12-26",{"date":343,"type":37},"2025-08-18",{"date":345,"type":22},"2026-12",{"name":82,"class":83},{"id":348,"slug":349,"hasResults":12,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":4,"eligibilityCriteria":353,"healthyVolunteers":354,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":357,"conditions":358,"keywords":370,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":383,"completionDateStruct":385,"leadSponsor":387,"locationsCount":84},"100615334","long-term-follow-up-of-the-offspring-born-to-mothers-with-a-solid-organ-transplant-transplantlines-next-generation-100615334","NCT07291258","Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant, Transplantlines Next Generation","Long-term Follow-up of the Offspring Born to Mothers With a Solid Organ Transplant","Inclusion Criteria:\n\n* Mother with a KTx, LiTx, PTx (including pancreas islet transplantation), HTx or LuTx before pregnancy (including mothers with multiple transplantation types)\n* Age ≥16 years for offspring born to mother with a KTx or LiTx\n\nExclusion Criteria:\n\n* No informed consent\n* Non Dutch or English speaking",true,{"count":356,"type":22},200,"Background Pregnancy after all types of solid organ transplantation (SOT) is possible, although these have higher risk of pregnancy complications for mother and child, such as preeclampsia and preterm birth. Thus, the development of the unborn child seems to be affected by the transplant and its consequences such as the immunosuppressive medication use. Worldwide data regarding follow-up after birth is scarce. The very limited existing data existing only in young children are reassuring. However, the investigators hypothesize that there are health risks for the children. Given the side effects of the immunosuppressive medication on patients and limited knowledge from animal studies, the investigators particularly expect cardiovascular effects such as hypertension and kidney damage. These develop over a long time-period and lead late to symptoms.\n\nAims Aim of this study is to gain more insight into the overall health of offspring born after SOT. Primary aim is to assess the cardiovascular health and the presence of kidney disease, and compare these with reference values from the general population or birth cohorts. Secondary aims are the immunological status including the microbiome of the child given the maternal immunosuppressive medication use, and the overall development of the offspring, including qualitative research regarding the quality of life. Third aim is to assess if there are differences in health between offspring born to mothers with a kidney, liver, pancreas (including pancreas islet), heart and lung transplantation (KTx, LiTx, PTx, HTx, LuTx resp.). The investigators also want to establish a biobank for later follow-up research.\n\nStudy design This will be a cross-sectional monocenter cohort study. All offspring ≥16 years of age born after KTx or LiTx and all offspring born at any age after PTx, HTx and LuTx in the Netherlands will be eligible for inclusion. The investigators estimate that there will be about 150(-220) participants. Before the study visit, participants will be asked to complete a questionnaire. Participants will be invited for a one-time study visit consisting of physical tests (including ultrasound of the kidneys and a 24-hour ambulatory blood pressure measurement) and biological sample (urine, blood and feces) collection, including sample collection for biobanking. Information about the growth and development of the offspring and, if present, diseases and medication use will be collected from the medical files of the general practitioner and pharmacy (LSP) and from data from the youth healthcare check-ups. As a control group pseudoanonymized data from the Lifelines cohort will be used.\n\nDeliverables To the best of our knowledge, this will be the first study worldwide that will gather and analyze detailed information about the cardiovascular, kidney and immunological health at a later age (≥16 years) in the offspring born to mothers after KTx, LiTx, PTx, HTx and LuTx. This information will be important for the preconceptional counseling of families with a pregnancy wish after transplantation and thereby contribute to the health of women with a SOT. Next to that, find adverse effects of the pregnancy after transplantation on the offspring are found, the investigators expect there will be modifiable factors and\u002For early screening\u002Finterventions that can reduce these risks and thereby contribute to the health of the offspring.",[359,360,361,60,28,362,363,364,365,366,367,368,369],"Solid Organ Transplantation","Pregnancy","Long-term Follow-up","Pancreas Transplant","Heart Transplantation","Lung Transplantation","Offspring, Adult","Children","Cardiovascular Abnormalities","Kidney Disease","Quality of Life",[371,360,372,373,374,375,376,377,378,379],"Solid organ transplantation","Offspring","Long-term follow-up","kidney transplantation","liver transplantation","pancreas transplantation","pancreas islet transplantation","Heart transplantation","lung transplantation","2025-12-04",{"date":382,"type":37},"2025-12-18",{"date":384,"type":37},"2025-10-15",{"date":386,"type":22},"2028-06",{"name":388,"class":83},"University Medical Center Groningen",{"id":390,"slug":391,"hasResults":12,"nctId":392,"briefTitle":393,"officialTitle":394,"acronym":4,"eligibilityCriteria":395,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":402,"lastUpdatePostDateStruct":403,"startDateStruct":405,"completionDateStruct":407,"leadSponsor":408,"locationsCount":84},"100378230","phase-2-cabozantinib-to-treat-recurrent-liver-cancer-post-transplant-100378230","NCT04204850","Cabozantinib to Treat Recurrent Liver Cancer Post Transplant","A Phase II Trial of Cabozantinib in the Treatment of Recurrent Hepatocellular Carcinoma Post Liver Transplant","Inclusion Criteria:\n\n* Have histologically or cytologically confirmed hepatocellular carcinoma that has recurred.\n* Previously underwent a liver transplant as a curative treatment for hepatocellular carcinoma (HCC).\n* Not amenable to curative surgery or local treatment for recurrent disease.\n* Must have measurable disease.\n* No prior treatment with cabozantinib. May be systemic therapy naïve or have received up to 1 line of prior therapy for advanced HCC with sorafenib or lenvatinib.\n* Age ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status 01.\n* Life expectancy of \\>3 months.\n* Normal organ and marrow function.\n* Adequate cardiac function.\n* No evidence of active uncontrolled infection.\n* Understand and willing to sign written informed consent document.\n* Recovered from prior toxicities to \\\u003C grade 1.\n* Able to take oral medications.\n* Agree to use effective contraceptive methods until at least 30 days (for women) and 3 months (for men) after the last administration of study medication. Serum pregnancy test should be negative.\n\nExclusion Criteria:\n\n* Had systemic therapy or radiotherapy \\\u003C3 weeks.\n* Receiving any other investigational agents.\n* With known brain metastases unless stable for \\>3 months.\n* History of allergic reactions attributed to cabozantinib.\n* Has uncontrolled, significant intercurrent or recent illness:\n* Cardiovascular disorders\n* Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation\n* Major surgery within 2 months before randomization\n* Cavitating pulmonary lesion(s) or endobronchial disease (untreated)\n* Lesion invading a major blood vessel\n* Clinically significant bleeding risk \\\u003C3 months\n* Other clinically significant disorders:\n* Active infection requiring systemic treatment, known infection with human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)-related illness\n* Serious non-healing wound\u002Fulcer\u002Fbone fracture\n* Malabsorption syndrome\n* Uncompensated\u002Fsymptomatic hypothyroidism\n* Requirement for hemodialysis or peritoneal dialysis\n* Pregnant women.\n* Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures\n* Active hepatitis B or C in liver graft\n* Patients with a grade \\>= 2 elevated liver enzymes who are suspected of cellular rejection will undergo biopsy. Patients diagnosed with cellular rejection in the biopsy sample using the Banff schema are ineligible.\n* Fibrolamellar carcinoma or mixed hepatocellular cholangiocarcinoma\n* Moderate or severe ascites\n* Concomitant use of anticoagulants at therapeutic doses\n* Has a known history of prior invasive malignancy except if patient has undergone curative-intent therapy with no evidence of disease recurrence for 2 years prior to study entry.",{"count":226,"type":22},[25],"This is a phase 2 study that will assess the investigational drug, cabozantinib, in patients with liver cancer (specifically hepatocellular carcinoma) and who had received a liver transplant as a part of curative care, but the cancer has come back (recurred). The purpose of this study is to see how useful cabozantinib is in controlling the disease of these patients.\n\nCabozantinib blocks the function of various proteins found on the surface of the body's cells (called receptor tyrosine kinases) that are important in the development of cancer tumors.\n\nAll participants will receive cabozantinib until they are no longer receiving benefit from the study drug or they experience an intolerable side effect.",[400,401,28],"Hepatocellular Carcinoma","Recurrent Cancer","2025-12-02",{"date":404,"type":37},"2025-12-03",{"date":406,"type":37},"2020-08-07",{"date":34,"type":22},{"name":409,"class":83},"University Health Network, Toronto",{"id":411,"slug":412,"hasResults":12,"nctId":413,"briefTitle":414,"officialTitle":414,"acronym":4,"eligibilityCriteria":415,"healthyVolunteers":12,"sex":18,"minAge":416,"maxAge":4,"enrollmentInfo":417,"targetDuration":4,"studyType":23,"phases":419,"briefSummary":420,"conditions":421,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":4},"100613485","phase-2-a-prospective-study-to-evaluate-the-efficacy-and-safety-of-entecavir-odt-conversion-in-stable-liver-transplant-patients-100613485","NCT07267208","A Prospective Study to Evaluate the Efficacy and Safety of Entecavir ODT Conversion in Stable Liver Transplant Patients","Inclusion Criteria:\n\n1. Patients aged 19 years or older.\n2. Patients who have maintained stable liver graft function for one year after liver transplantation due to HBV and meet the following conditions:\n\n   1. AST and ALT \\\u003C 35IU\u002FL\n   2. HBsAg: Negative\n   3. HBV DNA: Not detected\n3. Patients who have been taking entecavir for HBV prophylaxis for at least 1 year.\n4. Patients with a tacrolimus trough level maintained between 3-10 ng\u002FmL. 5 .Patients who have voluntarily decided to participate in the clinical trial after fully understanding the detailed explanation of the trial and have provided written consent.\n\nExclusion Criteria:\n\n1. Patients who have undergone transplantation of organs other than the liver or re-transplantation.\n2. Patients who have received bioartificial liver system treatment or auxiliary partial orthotopic liver transplantation (APOLT) before the transplantation.\n3. Patients with concurrent viral infections (HCV, HIV).\n4. Patients with eGFR \\\u003C30 or those undergoing dialysis\n5. Pregnant or breastfeeding women.\n6. Patients or their spouses\u002Fpartners who do not agree to use medically acceptable and appropriate contraception methods\\* during the clinical trial period.\n\n   \\* Appropriate contraception methods: hormonal contraception, intrauterine device (IUC or IUS), tubal ligation, tubal occlusion, hysterectomy, vasectomy, double barrier methods (combined use of male or female condoms with cervical caps, diaphragms, or contraceptive sponges), single barrier methods with spermicide.\n7. Patients with a history of hypersensitivity to Entecavir.\n8. Patients who are deemed unsuitable for participation in the clinical trial by the investigator.","19 Years",{"count":418,"type":22},82,[25],"This clinical study aims to evaluate the efficacy and safety of switching to entecavir orally disintegrating tablets (ETV-ODT) in liver transplant recipients with chronic hepatitis B, with a particular focus on the impact of the conversion on renal function.\n\nAfter providing written informed consent, participants will undergo screening assessments to determine eligibility based on the inclusion and exclusion criteria. Eligible participants who receive the investigational product will visit the study site at predetermined time points over a 48-week period to complete the scheduled study procedures.",[422,28],"Hepatitis B Virus","2025-11-24",{"date":425,"type":37},"2025-12-05",{"date":427,"type":22},"2025-12-01",{"date":429,"type":22},"2027-12-31",{"name":431,"class":83},"Jongman Kim",{"id":433,"slug":434,"hasResults":12,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":440,"conditions":441,"keywords":444,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":84},"100609586","liver-transplant-cgm-100609586","NCT07216508","Liver Transplant CGM","Post-discharge Glycemic Control After Liver Transplant and Impact on Transplant Outcomes","Inclusion Criteria:\n\n• inpatient liver transplant participants who have had an inpatient glucose greater than 180mg\u002FdL\n\nExclusion Criteria:\n\n* having a planned discharge to a rehabilitation or nursing facility,\n* a contraindication to sensor placement,\n* if discharge is anticipated to be \\>30 days post-transplant, or\n* if recent transplant also included a kidney or pancreas transplant",{"count":199,"type":22},"This investigator initiated study aims to describe continuous glucose monitoring (CGM) based glycemic metrics after discharge from liver transplant and assess relationship with glycemic metrics and liver transplant outcomes.",[28,442,443],"Post Transplant Diabetes","Type 2 Diabetes",[70,445,446,447,448],"hyperglycemia","diabetes","continuous glucose monitoring","glucose sensor","2025-11-10",{"date":451,"type":37},"2025-11-12",{"date":453,"type":37},"2025-10-13",{"date":455,"type":22},"2027-10-05",{"name":457,"class":83},"Icahn School of Medicine at Mount Sinai",{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":462,"acronym":4,"eligibilityCriteria":463,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":464,"enrollmentInfo":465,"targetDuration":4,"studyType":23,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":474,"leadSponsor":476,"locationsCount":84},"100522910","normothermic-machine-perfusion-of-steatotic-livers-for-expansion-of-donor-organ-pool-100522910","NCT06088758","Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool","Inclusion Criteria:\n\n* Age 18-80 years\n* Listed for liver transplantation at MGH\n* Calculated MELD-Na score \\\u003C= 25\n* Able to consent\n\nExclusion Criteria:\n\n* Status 1a\n* Cardiac or pulmonary disease\n* Prior liver transplant\n* Requiring pressors at the time of liver offer\n* MELD\\\u003C15 and asymptomatic from liver disease","80 Years",{"count":356,"type":22},[122],"The goal of this clinical trial is to assess the ability of Normothermic Machine Perfusion (NMP) to resuscitate moderately steatotic livers for transplantation in patients. This will be a single-site clinical trial placing donor livers with 30-60% macrosteatosis on NMP, and then transplanting those that meet commonly accepted viability criteria. The results of this study could lead to a trial extending NMP transplantation to severely steatotic livers, further expanding the donor organ pool.",[28],"2025-10-31",{"date":471,"type":37},"2025-11-03",{"date":473,"type":37},"2024-02-28",{"date":475,"type":22},"2027-07-31",{"name":477,"class":83},"Massachusetts General Hospital",{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":18,"minAge":485,"maxAge":19,"enrollmentInfo":486,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":487,"conditions":488,"keywords":490,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":504},"100607861","a-privacy-protecting-environment-for-child-transplants-health-related-and-genomic-data-integration-in-the-european-reference-network-100607861","NCT07194057","\"A Privacy-protecting Environment for Child Transplants Health Related and Genomic Data Integration in the European Reference Network\"","Protect_Child","Inclusion Criteria:\n\n* ● Paediatric patients (6 months to 18 years old) with liver or kidney transplant.\n\nBoth patients with de novo transplantation or in follow-up can be included in the study.\n\n* For the retrospective cohort, only patients within the first 5 years after transplantation will be included.\n* Patients and\u002For parents agreeing to participate in the study and provide consent for the obtention of clinical data and samples for genomic and methylomic analysis and the use of the information according to the protocol.\n\nExclusion Criteria:\n\n* Patients that are not being followed up in the clinical site.\n* Subjects alternating between different clinical sites. Subjects\u002FTutors that don't understand the informed consent form.\n* Subject or their legally authorized representative does not sign the informed consent document.\n* Re-transplantation or AB0-incompatible transplantation.","6 Months",{"count":356,"type":22},"Protect\\_Child\\_101 is an observational study to be performed in children that have undergone a liver or renal transplant.\n\nThe aim of this study is to analyse small variations in the genetic material (DNA) of transplanted children. The investigators will also study a type of chemical 'marks' called methylations, which do not change the DNA itself, but can affect how it functions. These marks can influence how certain diseases develop or how the body responds to transplantation.\n\nSpecifically, investigators seek to discover:\n\n* Whether there are genetic or epigenetic (methylation) alterations that may explain why some children develop serious diseases that require transplantation.\n* If these alterations can help us predict possible complications after transplantation, such as organ rejection, infections, organ failure, cancer development.\n\nWithin this study, data from the child's medical history will be collected. The data to be collected are demographic data (gender, age, ethnicity), clinical data, personal and family history possibly related to his\u002Fher disease, course and evolution of the disease, and complementary and laboratory examinations collected from his\u002Fher clinical history.\n\nThe only non-routine tests to be performed will be the genomic and methylomic tests. Nevertheless, these determinations will be performed on samples obtained during the child's routine care. No extra intervention is planned as part of this study.\n\nSamples and clinical data will be collected at different time points after transplantation. Schematically, collection is planned for months 0, 1, 3, 6, 12 and 24 post-transplant. In addition to these pre-established points, comprehensive data collection will be attempted when the child suffers a relevant clinical event, e.g. infection, treatment toxicity, organ rejection (post-transplant complication).",[489,60,28],"Transplant Complication",[491,492,493,494],"observational","epigenomic analysis","genomic analysis","european health data space","2025-09-25",{"date":497,"type":37},"2025-09-26",{"date":499,"type":22},"2025-09-30",{"date":501,"type":22},"2028-01",{"name":503,"class":83},"Instituto de Investigación Hospital Universitario La Paz",4,{"id":506,"slug":507,"hasResults":12,"nctId":508,"briefTitle":509,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":18,"minAge":512,"maxAge":513,"enrollmentInfo":514,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":516,"conditions":517,"keywords":540,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":544,"lastUpdatePostDateStruct":545,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":242},"100599630","cardiovascular-risk-in-children-with-chronic-conditions-study-100599630","NCT07086989","Cardiovascular Risk in Children With Chronic Conditions Study","CR3C","Inclusion criteria:\n\n1. Individuals aged between 6 and 25 years;\n2. Diagnosed with a chronic childhood condition\u002Fdisease associated with an increased risk of early cardiovascular disease;\n3. Provided informed consent (if over 18 years old) or had informed consent provided by their legal guardian (if under 18 years old) following appropriate information about the study.\n\nChronic childhood conditions\u002Fdiseases associated with increased risk of early cardiovascular disease are defined according to the 2019 American Heart Association recommendations (https:\u002F\u002Fdoi.org\u002F10.1161\u002FCIR.0000000000000618), as well as other conditions\u002Fdiseases for which at least two large-scale epidemiological studies have demonstrated an increased risk of cardiovascular disease.\n\nExclusion criteria:\n\n1. Severe intellectual and developmental disability;\n2. Decompensated heart failure;\n3. Severe primary immunodeficiency;\n4. Ongoing intravenous chemotherapy;\n5. Infectious diseases posing a public health risk; or\n6. History of regular alcohol or drug use.","6 Years","25 Years",{"count":515,"type":22},300,"Children living with chronic health conditions face a higher risk of developing cardiovascular diseases than their peers, largely due to the accelerated aging of the heart and blood vessels. Although experts recognize this elevated risk and recommend close monitoring and early intervention, the underlying mechanisms driving this phenomenon remain poorly understood. At present, no effective interventions specifically target its root causes.\n\nRecent research shows that both large blood vessels (such as the carotid artery) and small vessels (such as those in the retina) can display early signs of damage decades before clinically apparent heart or vascular disease emerges. This accelerated vascular aging can result from multiple factors - including disease-related processes such as persistent inflammation and metabolic disturbances, treatment-related effects such as chemotherapy or long-term steroid use, and lifestyle changes associated with chronic illness, such as reduced physical activity and altered eating habits. However, it is still unclear how these factors influence the development and progression of vascular changes in children as they grow. Importantly, these changes can be monitored through non-invasive methods, offering a unique opportunity to study at-risk patients many years before overt cardiovascular disease develops.\n\nIdentifying these early changes may enable us to detect and track individuals at heightened risk well in advance of clinical disease. This study aims to deepen our understanding of the causes of increased cardiovascular risk in children with chronic conditions and to lay the groundwork for earlier, more targeted prevention strategies.",[60,518,519,520,181,521,28,522,523,524,525,526,527,528,529,530,531,532,533,534,535,536,537,538,539],"Familial Hypercholesterolaemia","Type 1 Diabetes Mellitus (T1DM)","Type 2 Diabetes Mellitus (T2DM)","Kawasaki Disease","Obesity and Overweight","Hypertension","Coarctation of Aorta","Bone Marrow Transplant","Cancer (Solid Tumors)","Leukemia","Lymphoma","Lipoprotein(a)","Aorta Stenosis","Non Alcoholic Fatty Liver Disease","Dyslipaemia","White Coat Hypertension","Pulmonary Hypertension","Juvenile Idiopahtic Arthritis","Systemic Lupus Erthematosus","Inflammatory Bowel Disease (IBD)","HIV Infection","Transposition of Great Arteries",[541,542,543],"cardiovascular risk","vasculature","children with chronic conditions","2025-08-04",{"date":546,"type":37},"2025-08-08",{"date":548,"type":37},"2025-04-01",{"date":550,"type":22},"2029-01-31",{"name":552,"class":83},"Semmelweis University",{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":4,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":23,"phases":561,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":84},"100600827","phase-2-biliary-anastomosis-in-living-donor-liver-transplant-with-amniotic-tissue-100600827","NCT07102550","Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue","Biliary Anastomosis in Living Donor Liver Transplant With Amniotic Tissue: A Prospective Non-Randomized Clinical Trial","Inclusion Criteria:\n\n* Adults \\>\u002F= 18 years old\n* Recipient of LDLT\n\nExclusion Criteria:\n\n* Patients who are deemed unsafe for participation for any reason by our multi-disciplinary liver transplant selection committee.\n* Patients \\\u003C 18 years old\n* Patients who cannot provide informed consent\n* Patients receiving deceased donor liver transplants, or who are not undergoing Liver transplant (LT)\n* Patients who do not wish to participate\n* Children, cognitively-impaired persons, pregnant women, students and house staff under the direct supervision of the investigator are considered vulnerable populations and will, therefore, be excluded from participation.",{"count":199,"type":22},[25],"The goal of this single armed, non-randomized, pilot study is to demonstrate that placental tissue grafts are safe in living donor liver transplant and assess their impact on biliary outcomes in adults.",[28],[565,566],"Living Donor Liver Transplant","Liver Transplant Complications","2025-07-31",{"date":569,"type":37},"2025-08-03",{"date":571,"type":37},"2024-10-29",{"date":573,"type":22},"2027-07",{"name":575,"class":83},"Choon Hyuck David Kwon",{"id":577,"slug":578,"hasResults":12,"nctId":579,"briefTitle":580,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":23,"phases":585,"briefSummary":586,"conditions":587,"keywords":590,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":599,"leadSponsor":601,"locationsCount":84},"100593280","perioperative-use-of-amino-acids-in-recipients-of-orthotopic-liver-transplantation-as-a-renal-protective-factor-100593280","NCT07004387","Perioperative Use of Amino Acids in Recipients of Orthotopic Liver Transplantation as a Renal Protective Factor","PAATHO","Inclusion Criteria:\n\n* All patients assigned to receive a liver transplant will be evaluated for eligibility.\n* Patients over 18 years old scheduled for a liver transplant will be considered eligible if it is expected that they will have an ICU stay of at least 24 hours in the immediate postoperative period, regardless of the cause of liver failure and whether it was stable liver failure or acute on chronic liver failure.\n* They must have a baseline measurement of serum creatinine that does not exceed 30 days prior to surgery or can be taken before the transplant surgery.\n\nExclusion Criteria:\n\n* Patients under 18 years old will be excluded.\n* Patients with a need for chronic hemodialysis, patients with chronic kidney disease with an estimated glomerular filtration rate of less than 30 ml per minute per 1.73 square meters of body surface area calculated by the Cockcroft-Gault equation.\n* Patients with acute renal failure requiring acute intermittent or continuous renal replacement therapy during the hospitalization for surgery.\n* Patients who refuse informed consent to participate in the study.",{"count":584,"type":22},90,[122],"Orthotopic liver transplantation is the definitive treatment for end-stage liver failure, with renal failure being an important complication of this procedure that has implications for long- and short-term prognosis, affecting ICU stay and hospitalization time. Several studies have suggested that intravenous amino acids, particularly L-arginine, may have protective effects on renal function due to increased renal blood flow, which could be explained by enhanced production of nitric oxide among other mechanisms that are still unclear. In this context, we developed the hypothesis that the infusion of an amino acid solution in the perioperative period could reduce the incidence of acute renal failure in this group of patients; for this, we conducted a monocentric, analytical, prospective, interventional pilot study comparing standard treatment (in historically transplanted patients) with a group of patients who were administered amino acids in the perioperative period, considering that this medication is low-cost and has practically minimal side effects.",[588,28,589],"Hepatic Failure","Renal Failure, Acute",[70,591,592,593,594],"renal failiure","amino acids","surguery","ICU","2025-05-27",{"date":597,"type":37},"2025-06-04",{"date":595,"type":22},{"date":600,"type":22},"2026-09-30",{"name":602,"class":83},"Hospital Dr Sotero del Rio",{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":611,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":613,"conditions":614,"keywords":619,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":622,"lastUpdatePostDateStruct":623,"startDateStruct":625,"completionDateStruct":627,"leadSponsor":629,"locationsCount":84},"100564929","personalized-viscoelastic-testing-guided-bleeding-management-in-liver-surgery-neurosurgery-and-obstetrics-100564929","NCT06635564","Personalized ViscoElastic Testing-guided Bleeding Management In Liver Surgery, Neurosurgery and Obstetrics","Personalized ViscoElastic Testing-guided Bleeding Management In Liver Surgery, Neurosurgery and Obstetrics - a Prospective Comparison of the Novel ClotPro With ROTEM and TEG","VETILNO","Inclusion Criteria:\n\n1. Vulnerable patient cohorts\n\n   * Patients undergoing elective liver surgery defined as one of the following invasive procedures:\n\n     * Liver resection (anatomic or non-anatomic segmental resection, right or left hepatectomy, right or left extended hepatectomy),\n     * Orthotopic liver transplantation,\n   * Pregnant women undergoing an elective caesarean section, and\n   * Patients undergoing an elective intracranial neurosurgery.\n2. Written informed consent\n\nExclusion Criteria:\n\nnone",{"count":612,"type":22},240,"The ClotPro analyzer is a new generation viscoelastic analyzer for the in vitro assessment of blood coagulation. This study aims to assess the agreement of ClotPro 6.0, ROTEM delta, and TEG 6s in three distinct cohorts: i) patients with liver disease undergoing liver surgery, ii) pregnant women undergoing elective cesarean section, and iii) patients undergoing elective intracranial neurosurgery. Further coagulation tests will be performed (standard laboratory coagulation tests, thrombin and plasmin generation tests) in an exploratory fashion to compare them with viscoelastic test results. The obtained test results will not result in any diagnostic or therapeutic consequences for patients included in this study.",[615,28,616,617,618],"Thrombelastography","Postpartum Hemorrhage","Bleeding Disorder","Intracranial Hemorrhages",[620,621],"Viscoelastic testing","personalized bleeding management","2025-05-20",{"date":624,"type":37},"2025-05-23",{"date":626,"type":37},"2024-07-01",{"date":628,"type":22},"2026-07-31",{"name":630,"class":83},"Medical University of Vienna",{"id":632,"slug":633,"hasResults":12,"nctId":634,"briefTitle":635,"officialTitle":636,"acronym":4,"eligibilityCriteria":637,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":638,"enrollmentInfo":639,"targetDuration":4,"studyType":23,"phases":640,"briefSummary":641,"conditions":642,"keywords":643,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":84},"100532638","fluid-management-strategies-on-blood-loss-in-liver-transplantation-100532638","NCT06215404","Fluid Management Strategies on Blood Loss in Liver Transplantation","Effects of Different Fluid Management Strategies on Blood Loss, Inflammatory Response, and Major Organ Sequelae in Liver Transplantation","Inclusion Criteria:\n\n* end stage liver disease\n* age between 18y\u002Fo to 75 y\u002Fo\n* expected to recieve to receive liver transplantation\n\nExclusion Criteria:\n\n* arrythmia","75 Years",{"count":335,"type":22},[122],"During liver transplantation, due to the complexity of the operation and abnormal coagulation function, there may be a large amount of bleeding and corresponding blood transfusion. Excessive blood transfusion will increase pulmonary complications and affect the prognosis. Infusion management to reduce bleeding is a very important issue in liver transplant surgery. Restrictive infusion management can effectively reduce the amount of bleeding in liver transplantation, but it remains unclear whether it will cause sequelae in other major organs.\n\nThe investigators plan to study different infusion goals and strategies in liver transplant surgery using a randomized group model, using the PiCCO (Pulse Contour Cardiac Output) cardiopulmonary volume monitor, and setting the stroke volume variation (SVV) as the macroscopic circulation.The purpose of this study was to divide it into restrictive and liberal groups to explore the impact on liver transplantation bleeding volume and inflammatory response as well as postoperative lung and renal function, and to collect statistics on clinical care and postoperative sequelae (pulmonary liver, renal function impairment, etc.) in order to develop the most appropriate infusion management strategy in liver transplantation.",[28],[644,645],"fluid management","blood loss","2025-04-08",{"date":648,"type":37},"2025-04-11",{"date":650,"type":37},"2024-01-15",{"date":652,"type":22},"2025-12-31",{"name":654,"class":83},"National Taiwan University Hospital",{"id":656,"slug":657,"hasResults":12,"nctId":658,"briefTitle":659,"officialTitle":659,"acronym":4,"eligibilityCriteria":660,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":661,"enrollmentInfo":662,"targetDuration":93,"studyType":55,"phases":4,"briefSummary":664,"conditions":665,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":4},"100587440","efficacy-and-safety-of-liver-transplantation-for-hepatocellular-carcinoma-with-bile-duct-tumor-thrombus-a-single-arm-multicenter-prospective-study-hcc-bdtt-in-lt-100587440","NCT06928415","Efficacy and Safety of Liver Transplantation for Hepatocellular Carcinoma With Bile Duct Tumor Thrombus: a Single-arm, Multicenter, Prospective Study (HCC-BDTT in LT)","Inclusion Criteria:\n\n(1) age between 18 and 70 years; (2) Postoperative pathological diagnosis of HCC with BDTT requiring LT; (3) the general condition can tolerate the operation; (4) written informed consent given by the patient; (5) patients without distant metastasis.\n\nExclusion Criteria:\n\n(1) Those who did not undergo regular LT for various reasons, split LT, reduced-size LT, simultaneous transplantation, re-transplantation, multiple-organ recipients are excluded; (2) Additional surgical procedures such as pancreaticoduodenectomy were performed; (3) those with other diseases such as active pulmonary tuberculosis, coronary heart disease, renal insufficiency and so on, which affect the therapeutic effect; (4) Extensive abdominal metastasis was found during operation; (5) serious consequences or deaths caused by anesthesia accident during operation; (6) Postoperative death due to other diseases such as traffic accidents, cardiovascular and cerebrovascular accidents; (7) With distant metastasis before operation.","70 Years",{"count":663,"type":22},130,"The prognosis for patients diagnosed with hepatocellular carcinoma with bile duct tumor thrombus (BDTT-HCC) remains notably grim, as there are presently no universally accepted treatment guidelines in place to address this complex condition. Long-term outcomes of liver transplantation (LT) for BDTT-HCC are unclear, whether LT is a proper therapeutic option for BDTT-HCC patients remains to be determined. Therefore, we designed a clinical trial to evaluate survival of BDTT-HCC patients in LT. This is an open-labeled, single-arm, prospective, multicenter and real-world study designed to assess the survival outcomes of BDTT-HCC patients in LT. Patients will be enrolled based on histological confirmation of HCC with BDTT. The study will span a total of 4 years, including a 2-year enrollment phase and a subsequent 2-year follow-up period. We anticipate that LT will provide favorable survival benefits for BDTT-HCC patients, particularly in the key indicator recurrence-free survival (RFS) and improved quality of life. Upon successful completion of the trial, we will extend our monitoring over a longer follow-up time to accurately estimate important indicators such as overall survival (OS). We expect that this study will provide substantial evidence to refine treatment guidelines through thorough data analysis, ultimately contributing to better patient outcomes and advancing our understanding of the disease.",[28,400,666],"Bile Duct Tumor Thrombus","2025-04-07",{"date":669,"type":37},"2025-04-15",{"date":671,"type":22},"2025-04-10",{"date":673,"type":22},"2029-01-10",{"name":675,"class":83},"Zhejiang University",{"id":677,"slug":678,"hasResults":12,"nctId":679,"briefTitle":680,"officialTitle":681,"acronym":4,"eligibilityCriteria":682,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":683,"targetDuration":4,"studyType":23,"phases":684,"briefSummary":685,"conditions":686,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":688,"lastUpdatePostDateStruct":689,"startDateStruct":691,"completionDateStruct":693,"leadSponsor":695,"locationsCount":84},"100581978","perioperative-analgesia-with-erector-spinae-plane-block-in-liver-transplant-recipients-100581978","NCT06857331","Perioperative Analgesia With Erector Spinae Plane Block in Liver Transplant Recipients","Optimization of Perioperative Analgesia With Erector Spinae Plane Block During Major Abdominal Surgeries in Patients With Impaired Liver Function","Inclusion Criteria:\n\n* impaired liver function - cirrhosis or chronic liver disease with the development of hypocoagulation (APTT \\> 35 sec, INR \\> 1.5), thrombocytopenia, patients requiring major abdominal surgery, age \\> 18 years, written consent to participate in the study was obtained\n\nExclusion Criteria:\n\n* Platelet count \\\u003C50x109, failed ESP catheterization unilateral or bilateral, failed epidural anesthesia attempt, history of allergy or hypersensitivity to local anesthetics, hepatopulmonary syndrome, patients on mechanical ventilation before surgery, patients on CRRT before surgery, refusal to participate in the study",{"count":252,"type":22},[122],"The goal of this clinical trial is to learn if ESP block is safe and effective for perioperative analgesia in patients undergoing liver transplant. The main question it aims to answer are Is ESP block safe and has a minimum side effects, like hematoma? Is it effective for perioperative analgesia? Researchers will compare the results to a group of patients who underwent liver transplants without any regional anaesthesia techniques.\n\nParticipants will receive bilateral thoracic ESP block on the day of the transplantation with a subsequent bilateral catheterization.",[28,687],"Erector Spina Plan Block","2025-02-26",{"date":690,"type":37},"2025-03-04",{"date":692,"type":37},"2024-05-05",{"date":694,"type":22},"2025-12-10",{"name":696,"class":83},"Bogomolets National Medical University"]