[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intestinal-failure-associated-liver-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intestinal-failure-associated-liver-disease":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":30,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100608542",false,"NCT07202910","VALidation of Imaging-based Liver Biomarkers in PEDiatric Patients","Imaging-Based Biomarkers for Non-Invasive Pediatric Liver Diagnostics","VALiBi-PED","Inclusion Criteria (Study 1-main study)\n\n* all patients scheduled for a clinically liver biopsy at the Queen Silvia Children's Hospital\n* any form of suspected or confirmed liver disease\n* age between 0-18 years\n* consent by the child\u002Fparents to participate.\n* For controls: children scheduled for a renal biopsy\n* age between 0-18 years\n* consent by the child\u002Fparents to participate.\n\nExclusion Criteria:\n\n* technical limitations regarding the measurements\n* inability to fully understand the informed consent documents.",true,"ALL","25 Years",{"count":20,"type":21},550,"ESTIMATED","OBSERVATIONAL","The goal of this observational (diagnostic validation) study is to validate imaging-based biomarkers for assessing liver involvement in pediatric patients with established or suspected liver disease. The projekt involves 3 larger studies, each with specific aims specified in detailed description below.\n\nThe main study (study 1) compares imaging-based biomarkers-with liver biopsy to evaluate their correlation with histologically confirmed liver disease, including fibrosis, inflammation, and steatosis. The main question the overall project aims to answer is:\n\n• Can multiple novel imaging-based biomarkers, such as shear wave elastography (SWE), shear wave dispersion (SWD), and attenuation imaging (ATI), be used for detailed, non-invasive liver characterization in children, and if so, how should they be used?",[25,26,27,28,29],"Hepatic Disorders","Intestinal Failure-associated Liver Disease","Cystic Fibrosis Liver Disease","MAFLD","Pediatric Liver Transplantation",[31,32,33,34,27,35,36,37,38,28],"pediatric hepatic disease,","obesity and overweight","intestinal failiure associated liver disease","liver transplant disorder","Liver disease or abnormalities","pediatric liver transplant","pediatric abdominal imaging","elastography","RECRUITING","2025-09-23",{"date":42,"type":43},"2025-10-02","ACTUAL",{"date":45,"type":43},"2019-03-28",{"date":47,"type":21},"2032-12",{"name":49,"class":50},"Sahlgrenska University Hospital","OTHER",1,{"id":53,"slug":4,"hasResults":10,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":10,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100509918","NCT05919680","A Study of NST-6179 in Subjects With Intestinal Failure-Associated Liver Disease (IFALD).","A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orziloben (NST-6179) in Subjects With Intestinal Failure-Associated Liver Disease (IFALD)","Key Inclusion Criteria:\n\n* Adult persons aged 16 years or older at the time of informed consent.\n* Minimum of 6 months on Parenteral supplementation.\n* Established clinical diagnosis of IFALD based on a persistent elevation of\n\n  1. liver enzymes (ALP, AST, ALT, or GGT ≥1.5 × upper limit of normal \\[ULN\\]) for ≥6 months and\u002For\n  2. total bilirubin \\> ULN for ≥6 months.\n* Laboratory parameters consistent with stable liver disease without cirrhosis as defined by:\n\n  1. ALT and AST \\\u003C5 × ULN;\n  2. Total bilirubin ≤2.5 mg\u002FdL in the absence of Gilbert's Syndrome.\n  3. Serum albumin ≥2.5 g\u002FdL;\n  4. International normalized ratio (INR) ≤1.3 in the absence of anticoagulant therapy;\n  5. Platelet count ≥120,000\u002Fmm3.\n\nKey Exclusion Criteria:\n\n* Clinical, laboratory, imaging, or histopathologic evidence of other causes of acute or chronic liver disease, including autoimmune, viral, metabolic, or alcoholic liver disease.\n* Clinical evidence of compensated or decompensated hepatic cirrhosis as assessed by historical liver histology, ultrasound-based and\u002For signs and symptoms of hepatic decompensation (including, but not limited to, jaundice, ascites, variceal hemorrhage, and\u002For hepatic encephalopathy).\n* Presence of hepatic impairment, end-stage liver disease, and\u002For a model for end-stage liver disease (MELD) score \\>12.\n* Transient elastography read \\>20.0 kPA within 3 months prior to or during the Screening Period.\n* Estimated glomerular filtration rate \\\u003C45 mL\u002Fmin based on the 2021 CKD-EPI creatinine equation.\n* Poor nutritional status defined as body mass index (BMI) \\\u003C17 kg\u002Fm2.","16 Years",{"count":60,"type":21},36,"INTERVENTIONAL",[63],"PHASE2","This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of NST-6179 in subjects with intestinal failure-associated liver disease (IFALD) receiving parenteral nutrition (PN).\n\nThe study will be conducted in 2 sequential parts. Up to 36 subjects diagnosed with IFALD will be enrolled in the study, of which up to 18 subjects will be enrolled in each of the 2 parts and randomized (2:1) to receive NST-6179 (N=12\u002Fpart) or matched placebo (N=6\u002Fpart). Subjects in Part A will receive once daily (QD) oral administration of 800 mg (32 mL solution) NST-6179 or placebo for 4 weeks. The NST-6179 dose for Part B is planned to be 1200 mg QD for 12 weeks. Actual dose, however, will be determined during the safety review meeting.",[66],"Intestinal Failure Associated Liver Disease","2025-01-05",{"date":69,"type":43},"2025-01-07",{"date":71,"type":43},"2024-01-15",{"date":73,"type":21},"2025-06-30",{"name":75,"class":76},"NorthSea Therapeutics B.V.","INDUSTRY",13,""]