[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509918":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":42,"locations":48,"responsibleParty":222,"collaborators":32,"id":224,"slug":225,"hasResults":226,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":32,"eligibilityCriteria":230,"healthyVolunteers":226,"sex":231,"minAge":232,"maxAge":32,"enrollmentInfo":233,"targetDuration":32,"studyType":236,"phases":237,"briefSummary":239,"conditions":240,"keywords":32,"overallStatus":51,"whyStopped":32,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":251},{"fullName":5,"class":6},"NorthSea Therapeutics B.V.","INDUSTRY",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Part A-800 mg NST-6179","EXPERIMENTAL","up to 12 subjects",[13],"Drug: NST-6179 Part 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Adams",{"facility":210,"status":51,"city":211,"state":212,"zip":213,"country":55,"countryCode":56,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"University of Washington","Seattle","Washington","98195",{"type":58,"coordinates":215},[216,217],-122.33207,47.60621,{"lat":217,"lon":216},[220],{"name":221,"role":45,"phone":32,"phoneExt":32,"email":32},"Lei Yu, MD",{"type":223,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","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":234,"type":235},36,"ESTIMATED","INTERVENTIONAL",[238],"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.",[241],"Intestinal Failure Associated Liver Disease","2025-01-05",{"date":244,"type":245},"2025-01-07","ACTUAL",{"date":247,"type":245},"2024-01-15",{"date":249,"type":235},"2025-06-30",{"name":5,"class":6},13]