[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100476971":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":26,"centralContacts":30,"locations":36,"responsibleParty":173,"collaborators":34,"id":175,"slug":34,"hasResults":176,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":34,"eligibilityCriteria":180,"healthyVolunteers":176,"sex":181,"minAge":182,"maxAge":183,"enrollmentInfo":184,"targetDuration":34,"studyType":187,"phases":188,"briefSummary":190,"conditions":191,"keywords":195,"overallStatus":39,"whyStopped":34,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},{"fullName":5,"class":6},"PharmaIN","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"single dose of PHIN-214","EXPERIMENTAL","Participants in Part 1 will receive one dose of PHIN-214 administered subcutaneously. Dose level will be assigned in ascending doses to observe initial safety and tolerability. A Safety Committee will review information from each patient and determine the dose level for the subsequent participants.",[13],"Drug: PHIN-214 Subcutaneous injection",{"label":15,"type":10,"description":16,"interventionNames":17},"multiple daily dosing of PHIN-214","Participants in Part 2 will be trained to give themselves a daily dose of PHIN-214 at home by subcutaneous injection for 28-days. The dose level assigned to each participant will be determined by a Safety Committee after reviewing information from the last participants' experience and compilation of experiences on all previous participants. Dose level advancement will be guided throughout the study by the experiences and information collected from each participant.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","PHIN-214 Subcutaneous injection","subcutaneous injection(s) with PHIN-214 terlipressin derivative",[15,9],[25],"Terlipressin derivative",[27],{"name":28,"affiliation":5,"role":29},"Cynthia C Jones","STUDY_CHAIR",[31],{"name":28,"role":32,"phone":33,"phoneExt":34,"email":35},"CONTACT","206-568-1450",null,"PHIN.214001@pharmain.com",[37,56,71,86,101,116,131,146,159],{"facility":38,"status":39,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Arizona Liver Health","RECRUITING","Chandler","Arizona","85224","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-111.84125,33.30616,{"lat":49,"lon":48},[52],{"name":53,"role":32,"phone":54,"phoneExt":34,"email":55},"Angie Coste, FNP-C","480-470-4000","acoste@azliver.com",{"facility":57,"status":39,"city":58,"state":59,"zip":60,"country":43,"countryCode":44,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Southern California Research Center","Coronado","California","92118",{"type":46,"coordinates":62},[63,64],-117.18309,32.68589,{"lat":64,"lon":63},[67],{"name":68,"role":32,"phone":69,"phoneExt":34,"email":70},"Kasey Seyer","619-522-0330","kasey@researchscrc.com",{"facility":72,"status":39,"city":73,"state":74,"zip":75,"country":43,"countryCode":44,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Tandem Clinical Research","Marrero","Louisiana","70072",{"type":46,"coordinates":77},[78,79],-90.10035,29.89937,{"lat":79,"lon":78},[82],{"name":83,"role":32,"phone":84,"phoneExt":34,"email":85},"Alexis Johnson","504-934-8424","AJohnson@tandemclinicalresearch.com",{"facility":87,"status":39,"city":88,"state":89,"zip":90,"country":43,"countryCode":44,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Mayo Clinic","Rochester","Minnesota","55905",{"type":46,"coordinates":92},[93,94],-92.4699,44.02163,{"lat":94,"lon":93},[97],{"name":98,"role":32,"phone":99,"phoneExt":34,"email":100},"Amy Olofson, RN","507-538-6547","Olofson.Amy@mayo.edu",{"facility":102,"status":39,"city":103,"state":104,"zip":105,"country":43,"countryCode":44,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Cleveland Clinic","Cleveland","Ohio","44195",{"type":46,"coordinates":107},[108,109],-81.69541,41.4995,{"lat":109,"lon":108},[112],{"name":113,"role":32,"phone":114,"phoneExt":34,"email":115},"Keralee Morey","216-215-0808","moreyk@ccf.org",{"facility":117,"status":39,"city":118,"state":119,"zip":120,"country":43,"countryCode":44,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",{"type":46,"coordinates":122},[123,124],-75.16362,39.95238,{"lat":124,"lon":123},[127],{"name":128,"role":32,"phone":129,"phoneExt":34,"email":130},"Margaret Bussineau","215-615-3755","Margaret.Bussineau@Pennmedicine.upenn.edu",{"facility":132,"status":39,"city":133,"state":134,"zip":135,"country":43,"countryCode":44,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"Methodist Health System, Dallas Medical Center","Dallas","Texas","75203",{"type":46,"coordinates":137},[138,139],-96.80667,32.78306,{"lat":139,"lon":138},[142],{"name":143,"role":32,"phone":144,"phoneExt":34,"email":145},"Crystee Cooper","214-947-1280","clinicalresearch@mhd.com",{"facility":147,"status":39,"city":133,"state":134,"zip":148,"country":43,"countryCode":44,"cosmosGeoPoint":149,"geoPoint":151,"contacts":152},"VA North Texas Healthcare System","75216",{"type":46,"coordinates":150},[138,139],{"lat":139,"lon":138},[153,157],{"name":154,"role":32,"phone":155,"phoneExt":34,"email":156},"Jacqueline O'Leary, MD","214-857-0403","Jacqueline.Oleary@va.gov",{"name":154,"role":158,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"facility":160,"status":39,"city":161,"state":134,"zip":162,"country":43,"countryCode":44,"cosmosGeoPoint":163,"geoPoint":167,"contacts":168},"Texas Liver Institute","San Antonio","78215",{"type":46,"coordinates":164},[165,166],-98.49363,29.42412,{"lat":166,"lon":165},[169],{"name":170,"role":32,"phone":171,"phoneExt":34,"email":172},"Eric Lawitz, MD","210-253-3426","Lawitz@txliver.com",{"type":174,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100476971",false,"NCT05490888","Single and Multiple Dose Escalation of PHIN-214 in Child-Pugh A and B Liver Cirrhotics","A Phase 1 Open Label Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PHIN-214 in Adults With Child Pugh A and B Cirrhosis","Key Inclusion Criteria:\n\n1. History of cirrhosis based on histology or a combination of clinical, radiological, or biochemical assessment and classified as Child-Pugh A or B\n2. Participants may be male or female aged 18 to 75 years.\n3. Body mass index (BMI) within the range 18 to 40 kg\u002Fm2 (inclusive) at screening.\n4. Female participants must be non-pregnant, non-lactating, or of non-childbearing potential or using highly efficient contraception for the full duration of the study\n\nKey Exclusion Criteria:\n\n1. Significant abnormalities in medical history or on physical examination, including: respiratory disease requiring therapy or history of respiratory failure, cardiovascular disease or hypertension, electrocardiogram abnormalities or history of significant EKG abnormalities.\n2. History of diabetes insipidus, syndrome of inappropriate antidiuretic hormone secretion, or any other disorder associated with fluid or sodium imbalance.\n3. Significant kidney disease\n4. Hepatic encephalopathy (HE) or altered mental status requiring hospitalization; variceal bleeding or upper gastrointestinal bleeding; or type 1 hepatorenal syndrome with acute kidney injury (HRS-AKI) during the previous 3 months prior to Screening.\n5. Acute-on-chronic liver failure.\n6. Recipient of a patent transjugular intrahepatic portosystemic shunt (TIPS).\n7. Known positive HIV serology confirmed by HIV viral load.\n8. Subjects with acute infections, including acute viral hepatitis (subjects with chronic hepatitis B are eligible if treatment regimen is stable ≥ 3 months prior to study inclusion).","ALL","18 Years","75 Years",{"count":185,"type":186},74,"ESTIMATED","INTERVENTIONAL",[189],"PHASE1","This 2-part study will evaluate PHIN-214 given as a single one-time dose (Part 1) and in multiple doses (given as daily doses for 28-days) (in Part 2). Specifically, this study evaluates PHIN-214, to determine the safety, tolerability, and pharmacokinetic effects of PHIN-214, and to establish the maximum tolerated dose or optimal beneficial dose in patients with Child Pugh A and B Cirrhosis.",[192,193,194],"Cirrhosis, Liver","Liver Fibrosis","Ascites Hepatic",[196,197,198,199],"Terlipressin","Cirrhosis","Vasoconstrictor","Refractory Ascites","2025-09-03",{"date":202,"type":203},"2025-09-05","ACTUAL",{"date":205,"type":203},"2022-01-03",{"date":207,"type":186},"2026-06-30",{"name":5,"class":6},9]