[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"end-stage-liver-disease-esld\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:end-stage-liver-disease-esld":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100640555","establishing-a-reference-framework-for-outcomes-after-machine-preserved-liver-transplantation-in-europe-100640555",false,"NCT07585890","Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe","Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe (REFRAME-MP)","REFRAME-MP","Inclusion Criteria:\n\n* All postmortal livers accepted (transplanted and not-transplanted after machine perfusion) upon organ offer for patients \\>18 years at the time of liver transplantation.\n* All donor types (DBD, DCD)\n* Preservation either with static cold storage alone or combined with machine perfusion (MP).\n* Donor livers underwent MP as part of routine clinical practice and the choice of perfusion protocol was made according to institutional standard practice.\n* Eligible MP protocols are:\n\n  1. end-ischemic single- or dual hypothermic oxygenated MP \\[e(D)HOPE\\],\n  2. end-ischemic (back-to-base) normothermic MP \\[eNMP\\],\n  3. continuous (device-to-donor) normothermic MP \\[cNMP\\],\n  4. e(D)HOPE followed by controlled oxygenated rewarming and normothermic MP \\[e(D)HOPE-COR-NMP)\\],\n  5. e(D)HOPE followed by normothermic MP \\[e(D)HOPE-NMP\\], or\n  6. Normothermic regional perfusion followed by SCS or an ex situ MP protocol.\n* A minimum follow-up of 12 months after liver transplantation is required.\n\nExclusion Criteria:\n\n* Livers that were allocated to a MP protocol as part of a prospective randomized or interventional clinical trial comparing different preservation techniques or any other invention.\n* Living donor liver transplantation","ALL","18 Years",{"count":20,"type":21},10000,"ESTIMATED","OBSERVATIONAL","Machine perfusion (MP) has become routine clinical practice in liver transplantation. However, as the field has matured, direct randomized comparisons between distinct MP modalities have become increasingly impractical, given that donor and graft characteristics often predetermine the optimal preservation strategy. Consequently, many studies continue to reference historical benchmark cohorts from the pre-perfusion era, or use risk scores developed before routine utilization of MP. These cohorts, while once valuable, fail to account for the paradigm shift that MP has introduced. Likewise, commonly used donor- and recipient-based risk scores were developed prior to the adoption of MP. While these scores aim to assess survival or morbidity after transplantation, none of them guide decisions about MP use or the most suitable perfusion protocol. As MP technologies continue to evolve there is a critical need for an updated reference framework that accurately reflects current clinical practice and captures the best achievable outcomes across all MP modalities.",[25,26,27,28],"End-stage Liver Disease (ESLD)","Acute Liver Failure","Liver Cirrhosis","Liver Transplantation",[30,31,32,33,34,35,36],"machine perfusion","liver transplantation","hypothermic machine perfusion","normothermic machine perfusion","normothermic regional perfusion","organ preservation","machine preservation","RECRUITING","2026-05-11",{"date":40,"type":41},"2026-05-14","ACTUAL",{"date":43,"type":41},"2026-04-21",{"date":45,"type":21},"2030-12-31",{"name":47,"class":48},"University Medical Center Groningen","OTHER",2,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":65,"conditions":66,"keywords":74,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":101},"100579393","phase-1-rtx001-autologous-engineered-macrophages-for-liver-cirrhosis-100579393","NCT06823713","RTX001 Autologous Engineered Macrophages for Liver Cirrhosis","An Open-label Phase 1\u002F2 Multicentre Study to Evaluate the Safety, Tolerability and Efficacy of RTX001 Autologous Macrophages in Participants With Liver Cirrhosis Who Have Hepatic Decompensation (EMERALD)","EMERALD","Individuals eligible to participate in this study must meet the following criteria:\n\nInclusion Criteria:\n\n1. Male or female age ≥18-75 years.\n2. Patient confirms willingness\u002Fability to comply with all study procedures.\n3. Diagnosis of liver cirrhosis based on at least one of:\n\n   1. Clinical and radiological features that correlate with a diagnosis of cirrhosis.\n   2. Transient elastography (Fibroscan) \\>15 kPa.\n   3. Previous liver biopsy confirming histological features of cirrhosis.\n4. Aetiology of liver disease of steatotic liver disease including MASLD or Met-ALD or ALD\n\n   a. Participants with alcohol-related liver disease (ALD or Met-ALD) only if they are confirmed to not be drinking alcohol above Met-ALD limits defined in this protocol. (N.B. No more than 34% of the total treated participants in this protocol will be ALD \\[excludes Met-ALD\\]).\n5. Hospitalised as an inpatient for a recent major hepatic decompensation event including ascites, hepatic encephalopathy, variceal bleed, HRS-AKI or SBP, this being the only hospitalisation for an hepatic decompensation event hospitalisation within the last 6 months, and where recent is defined as within 6 weeks of hospital discharge.\n6. Outpatient: Medically refractory ascites (ONLY), that recurs (i.e., second therapeutic LVP) within a 6-month period. Medically refractory ascites is defined by the repeated (≥2) need for LVP (i.e., therapeutic, not diagnostic) at least once per 8 weeks despite best medical attempts to control the ascites by sodium restriction and diuretic treatment, as confirmed by the Investigator. Onset is defined as the date of the second therapeutic LVP.\n7. Confirmatory PEth alcohol test \\\u003C200 ng\u002Fml\n8. MELD score of 12-20 taken within two weeks of 'qualifying' decompensation event.\n9. No known contradictions to filgrastim or leukapheresis procedure.\n10. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n11. Willing and able to give signed informed consent, and if applicable assent.\n\nParticipants are excluded from the study if any of the following criteria apply:\n\nExclusion Criteria:\n\n1. Liver cirrhosis due to:\n\n   1. any viral hepatitidies, or\n   2. autoimmune and cholestatic aetiologies including, but not limited to, primary biliary cholangitis and primary sclerosing cholangitis.\n2. Acute liver disease in the absence of underlying liver cirrhosis, including, but not limited to, drug induced liver injury.\n3. Any current organ failure requiring more than outpatient supportive care, and not associated with the participant's qualifying hepatic decompensation event.\n4. Known splenomegaly ≥16 cm.\n5. Thrombocytopenia \\\u003C50×109\u002FL.\n6. Presence or suspicion of any of the following co-morbidities:\n\n   1. History of liver transplantation or other organ transplant.\n   2. ACLF.\n   3. Sepsis (with positive microbial cultures) or as defined by the Principal Investigator, unless stable and is at least 4 weeks after having completed a full course of IV antibiotics.\n   4. Known human immunodeficiency virus.\n   5. Known syphilis.\n   6. Known human T-lymphotropic virus 1.\n   7. Pulmonary embolism.\n   8. Hepatocellular carcinoma, or any active malignant disease within the last five years, (excluding non-melanoma skin cancer, cervical carcinoma in situ, superficial bladder cancer, benign polyps etc.).\n   9. Co-hepatic morbidities e.g., portal vein thrombosis.\n   10. Participants with hepatic hydrothorax are excluded unless it is a small hydrothorax, not clinically apparent, that is detected incidentally by radiologic evaluation that does not require clinical intervention.\n   11. Chronic renal impairment (on dialysis) or unresolved AKI.\n   12. Acute or chronic heart failure (New York Heart Association Grade III\u002FIV).\n   13. Porto-pulmonary hypertension.\n   14. Severe chronic lung disease e.g., chronic obstructive pulmonary disease or interstitial lung disease where the forced expiratory volume in the first second (FEV1) is less than 50% and\u002For FEV1\u002Fforced vital capacity is less than 60%.\n   15. Hepatopulmonary syndrome.\n   16. Previous or current treatment with multiple infusions of albumin for therapeutic intent. \\[Use of albumin infusion at the time of large volume paracentesis for circulatory support is allowed.\\]\n   17. Significant untreated\u002Funstable psychiatric disease.\n   18. Transjugular intrahepatic portosystemic shunt (TIPSS).\n7. As judged by the Investigator, any evidence of intercurrent illness that is either life threatening or of clinical significance such that it might limit compliance with study procedures.\n8. Current or planned use of immunomodulators or immunosuppressive medication; note: low doses of corticosteroids up to 10 mg\u002Fkg\u002Fday prednisone or equivalent are permitted, or inhaled steroids to manage asthma.\n9. Received a gene or cell therapy at any time.\n10. Current or planned use of a live attenuated vaccines four weeks or fewer prior to enrolment (and for 3 months after the last administered dose of RTX001).\n11. Received any investigational product within the past 6 months, or five half-lives (whichever is longer) or participated in another investigational interventional study within 30 days prior to the screening visit.\n12. Participants with a known hypersensitivity to dimethyl sulfoxide (DMSO).\n13. Judgment by the Investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions and requirements.\n14. For female participants only - pregnant or breast-feeding or plans to become pregnant over the next year, or of childbearing potential and unwilling to comply with contraceptive requirements.\n15. Alcohol misuse in the period between identification of the participant as potentially suitable for this study to Screening (Visit 1), defined as alcohol intake greater than three units\u002Fday for females and four units\u002Fday for males, or binge drinking (\\>14 units\u002Fday) as determined by the Investigator. N.B. One unit is equivalent to 14 g of alcohol: a half-pint (\\~240 mL) of beer, one glass (125 mL) of wine or one (25 mL) measure of spirits.\n16. Intake of non-medically supervised drugs of abuse that are judged (by the Investigator) to be a high risk to the participants acute health or which makes the participant likely to be non-compliant with follow-up.","75 Years",{"count":60,"type":21},30,"INTERVENTIONAL",[63,64],"PHASE1","PHASE2","The purpose of this study is to assess the safety and efficacy of RTX001 in patients with end-stage liver disease. This study is the first time RTX001, a macrophage cell therapy engineered to have an anti-inflammatory and anti-fibrotic effect, will be given to humans.",[25,67,68,69,70,71,72,73],"Cirrhosis, Liver","Cirrhosis, Decompensated","Liver Diseases","Fibrosis and Cirrhosis of Liver","Decompensated Liver Cirrhosis","Decompensated Cirrhosis","Steatotic Liver Disease",[75,76,77,78,79,71,80,81,82,83,84,85,86,87,88,89,90,73],"Liver cirrhosis","Cirrhotic","Hepatic Cirrhosis","Chronic Liver Disease","Liver Fibrosis","Child-Pugh Score","MELD Score","Liver Function Tests","Hepatic Encephalopathy","End Stage Liver Disease (ESLD)","Variceal Bleeding","Jaundice","Retractable Ascites","Autologous","Cell Therapy","Macrophage","2026-01-27",{"date":93,"type":41},"2026-01-28",{"date":95,"type":41},"2024-10-15",{"date":97,"type":21},"2028-11-29",{"name":99,"class":100},"Resolution Therapeutics Limited","NETWORK",14,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":61,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":128},"100605062","efficacy-and-safety-of-tranexamic-acid-in-adult-liver-transplantation---esta-trial-100605062","NCT07157631","Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation---ESTA Trial","A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Trial to Evaluate the Efficacy and Safety of Tranexamic Acid in Adult Liver Transplantation (ESTA Trial)","ESTA","Inclusion Criteria:consenting adults aged at least 18 years who are scheduled for allogeneic liver transplantation with general anesthesia.\n\n\\-\n\nExclusion Criteria:1) History of arterial or venous thrombosis within 3 months; 2) Re-transplantation; 3) Known allergy to tranexamic acid; 4) Participation in potentially conflicting clinical trials; 5) Considered by the responsible surgeon or anesthesiologist to be unsuitable.\n\n\\-",{"count":111,"type":21},1546,[113],"NA","We propose a multi-center randomized trial to test the primary hypothesis that tranexamic acid is superior to placebo on blood loss in adult orthotopic liver transplantation within the initial 24 hours and that tranexamic acid is non-inferior to placebo for a composite of thrombotic events within the initial 7 postoperative days. Secondarily, we will determine whether tranexamic acid is superior to placebo on total postoperative drainage volume and blood product transfusion within the initial 3 postoperative days.\n\nWe propose to randomize patients to 2.0 g of tranexamic acid intravenously at the start of surgery or a comparable volume of 0.9% normal saline placebo. Because demonstrating safety will require more patients, our sample size is based on safety. Randomizing 1546 patients will provide 80% power for detecting a non-inferiority margin of 4% with a baseline incidence of 10% for composite thrombotic events within the initial 7 postoperative days.",[28,116,25],"Tranexamic Acid",[28,118],"tranexamic acid","2025-12-02",{"date":121,"type":41},"2025-12-08",{"date":123,"type":41},"2025-11-01",{"date":125,"type":21},"2027-12-01",{"name":127,"class":48},"RenJi Hospital",1]