[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100509918":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":42,"locations":48,"responsibleParty":221,"collaborators":32,"id":223,"slug":32,"hasResults":224,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":32,"eligibilityCriteria":228,"healthyVolunteers":224,"sex":229,"minAge":230,"maxAge":32,"enrollmentInfo":231,"targetDuration":32,"studyType":234,"phases":235,"briefSummary":237,"conditions":238,"keywords":32,"overallStatus":51,"whyStopped":32,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":249},{"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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Yokley","CONTACT","+31 (0) 35 760 65 05","michelle.yokley@northseatherapeutics.com",[49,65,78,92,105,118,131,144,157,169,182,195,208],{"facility":50,"status":51,"city":52,"state":53,"zip":54,"country":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Mayo Clinic Scottsdale Campus","RECRUITING","Scottsdale","Arizona","85259","United States",{"type":57,"coordinates":58},"Point",[59,60],-111.89903,33.50921,{"lat":60,"lon":59},[63],{"name":64,"role":45,"phone":32,"phoneExt":32,"email":32},"John DiBaise, MD",{"facility":66,"status":51,"city":67,"state":68,"zip":69,"country":55,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"University of California San Francisco Medical Center","San Francisco","California","94143",{"type":57,"coordinates":71},[72,73],-122.41942,37.77493,{"lat":73,"lon":72},[76],{"name":77,"role":45,"phone":32,"phoneExt":32,"email":32},"Kendall Beck, 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Adams",{"facility":209,"status":51,"city":210,"state":211,"zip":212,"country":55,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"University of Washington","Seattle","Washington","98195",{"type":57,"coordinates":214},[215,216],-122.33207,47.60621,{"lat":216,"lon":215},[219],{"name":220,"role":45,"phone":32,"phoneExt":32,"email":32},"Lei Yu, MD",{"type":222,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","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":232,"type":233},36,"ESTIMATED","INTERVENTIONAL",[236],"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.",[239],"Intestinal Failure Associated Liver Disease","2025-01-05",{"date":242,"type":243},"2025-01-07","ACTUAL",{"date":245,"type":243},"2024-01-15",{"date":247,"type":233},"2025-06-30",{"name":5,"class":6},13]