[{"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":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100608542","validation-of-imaging-based-liver-biomarkers-in-pediatric-patients-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":21,"type":22},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?",[26,27,28,29,30],"Hepatic Disorders","Intestinal Failure-associated Liver Disease","Cystic Fibrosis Liver Disease","MAFLD","Pediatric Liver Transplantation",[32,33,34,35,28,36,37,38,39,29],"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":43,"type":44},"2025-10-02","ACTUAL",{"date":46,"type":44},"2019-03-28",{"date":48,"type":22},"2032-12",{"name":50,"class":51},"Sahlgrenska University Hospital","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":18,"minAge":60,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100509918","phase-2-a-study-of-nst-6179-in-subjects-with-intestinal-failure-associated-liver-disease-ifald-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":62,"type":22},36,"INTERVENTIONAL",[65],"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.",[68],"Intestinal Failure Associated Liver Disease","2025-01-05",{"date":71,"type":44},"2025-01-07",{"date":73,"type":44},"2024-01-15",{"date":75,"type":22},"2025-06-30",{"name":77,"class":78},"NorthSea Therapeutics B.V.","INDUSTRY",13]