[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NorthSea Therapeutics B.V.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100509918","phase-2-a-study-of-nst-6179-in-subjects-with-intestinal-failure-associated-liver-disease-ifald-100509918",false,"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.","ALL","16 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26],"Intestinal Failure Associated Liver Disease","RECRUITING","2025-01-05",{"date":30,"type":31},"2025-01-07","ACTUAL",{"date":33,"type":31},"2024-01-15",{"date":35,"type":20},"2025-06-30",{"name":37,"class":38},"NorthSea Therapeutics B.V.","INDUSTRY",13,""]