[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05490888":3,"trial-entities:NCT05490888":197,"trial-summary:NCT05490888":200},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":44,"secondary_outcomes":56,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":15,"eligibility_criteria":63,"std_ages":67,"locations":70,"central_contacts":187,"overall_officials":192,"references":195,"see_also_links":196},"NCT05490888","PHIN-001","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","RECRUITING","2026-06-30","2025-09","2025-09-05","2022-01-03","PharmaIN","INDUSTRY",false,"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.","PHIN-214 action has similar actions as another medication called \"terlipressin or TERLIVAZ®.\" Terlipressin has been shown to reduce portal hypertension, improve renal function, and induce natriuresis in cirrhotic patients with ascites without hepatorenal syndrome (HRS). It is approved in several countries including the US for the treatment of bleeding esophageal varices and HRS type 1 and is usually administered using multiple IV doses given by bolus injections in the hospital.\n\nThis study is an open label, first in human study of PHIN-214. PHIN-214 is a terlipressin derivative administered subcutaneously. It is a partial V1a agonist which is designed to reduce splanchnic blood pooling and portal hypertension. A resultant increase in systemic pressure and renal arterial pressure may increase kidney perfusion and creatinine clearance.\n\nThis study will evaluate a single dose of PHIN-214 (in Part 1) and in Part 2, daily doses of PHIN-214 for up to 28-days (called multiple ascending doses) of PHIN-214 to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of PHIN-214 in subjects with advanced cirrhosis.",[19,20,21],"Cirrhosis, Liver","Liver Fibrosis","Ascites Hepatic",[23,24,25,26],"Terlipressin","Cirrhosis","Vasoconstrictor","Refractory Ascites","INTERVENTIONAL","TREATMENT",[30],"PHASE1",{"count":32,"type":33},74,"ESTIMATED",[35],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":42},"DRUG","PHIN-214 Subcutaneous injection","subcutaneous injection(s) with PHIN-214 terlipressin derivative",[40,41],"multiple daily dosing of PHIN-214","single dose of PHIN-214",[43],"Terlipressin derivative",[45,49,53],{"measure":46,"description":47,"timeFrame":48},"maximum tolerated dose or optimal beneficial dose of PHIN-214 in multiple ascending dose; safety and tolerability.","Incidence of adverse effects (type and severity), incidence of dose limiting toxicities, changes in key laboratory measures","may be up to six weeks",{"measure":50,"description":51,"timeFrame":52},"Pharmacokinetics of PHIN-214","plasma concentration of PHIN-214","up to six weeks",{"measure":54,"description":55,"timeFrame":52},"Pharmacokinetics of PHIN-214 metabolite","plasma concentration of PHIN-214 metabolite",[57],{"measure":58,"description":59,"timeFrame":52},"Immunogenicity of PHIN-214","anti-drug antibody testing","ALL","18 Years","75 Years",{"inclusion":64,"exclusion":65,"raw_text":66},[],[],"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).",[68,69],"ADULT","OLDER_ADULT",[71,86,99,112,125,138,151,164,175],{"facility":72,"status":8,"city":73,"state":74,"zip":75,"country":76,"contacts":77,"geoPoint":83},"Arizona Liver Health","Chandler","Arizona","85224","United States",[78],{"name":79,"role":80,"phone":81,"email":82},"Angie Coste, FNP-C","CONTACT","480-470-4000","acoste@azliver.com",{"lat":84,"lon":85},33.30616,-111.84125,{"facility":87,"status":8,"city":88,"state":89,"zip":90,"country":76,"contacts":91,"geoPoint":96},"Southern California Research Center","Coronado","California","92118",[92],{"name":93,"role":80,"phone":94,"email":95},"Kasey Seyer","619-522-0330","kasey@researchscrc.com",{"lat":97,"lon":98},32.68589,-117.18309,{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":76,"contacts":104,"geoPoint":109},"Tandem Clinical Research","Marrero","Louisiana","70072",[105],{"name":106,"role":80,"phone":107,"email":108},"Alexis Johnson","504-934-8424","AJohnson@tandemclinicalresearch.com",{"lat":110,"lon":111},29.89937,-90.10035,{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":76,"contacts":117,"geoPoint":122},"Mayo Clinic","Rochester","Minnesota","55905",[118],{"name":119,"role":80,"phone":120,"email":121},"Amy Olofson, RN","507-538-6547","Olofson.Amy@mayo.edu",{"lat":123,"lon":124},44.02163,-92.4699,{"facility":126,"status":8,"city":127,"state":128,"zip":129,"country":76,"contacts":130,"geoPoint":135},"Cleveland Clinic","Cleveland","Ohio","44195",[131],{"name":132,"role":80,"phone":133,"email":134},"Keralee Morey","216-215-0808","moreyk@ccf.org",{"lat":136,"lon":137},41.4995,-81.69541,{"facility":139,"status":8,"city":140,"state":141,"zip":142,"country":76,"contacts":143,"geoPoint":148},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",[144],{"name":145,"role":80,"phone":146,"email":147},"Margaret Bussineau","215-615-3755","Margaret.Bussineau@Pennmedicine.upenn.edu",{"lat":149,"lon":150},39.95238,-75.16362,{"facility":152,"status":8,"city":153,"state":154,"zip":155,"country":76,"contacts":156,"geoPoint":161},"Methodist Health System, Dallas Medical Center","Dallas","Texas","75203",[157],{"name":158,"role":80,"phone":159,"email":160},"Crystee Cooper","214-947-1280","clinicalresearch@mhd.com",{"lat":162,"lon":163},32.78306,-96.80667,{"facility":165,"status":8,"city":153,"state":154,"zip":166,"country":76,"contacts":167,"geoPoint":174},"VA North Texas Healthcare System","75216",[168,172],{"name":169,"role":80,"phone":170,"email":171},"Jacqueline O'Leary, MD","214-857-0403","Jacqueline.Oleary@va.gov",{"name":169,"role":173},"PRINCIPAL_INVESTIGATOR",{"lat":162,"lon":163},{"facility":176,"status":8,"city":177,"state":154,"zip":178,"country":76,"contacts":179,"geoPoint":184},"Texas Liver Institute","San Antonio","78215",[180],{"name":181,"role":80,"phone":182,"email":183},"Eric Lawitz, MD","210-253-3426","Lawitz@txliver.com",{"lat":185,"lon":186},29.42412,-98.49363,[188],{"name":189,"role":80,"phone":190,"email":191},"Cynthia C Jones","206-568-1450","PHIN.214001@pharmain.com",[193],{"name":189,"affiliation":13,"role":194},"STUDY_CHAIR",[],[],{"nct_id":4,"conditions":198,"biomarkers":199},[24],[],{"nct_id":4,"found":201,"summary":202,"prompt_version":212},true,{"design":203,"status":204,"heading":205,"summary":206,"follow_up":207,"word_count":208,"commitments":209,"compensation":210,"drugs_mentioned":211},"This is an open-label study, meaning both you and the study team will know which treatment you are receiving. It will involve about 74 participants and will test PHIN-214 first as a single dose, then as daily doses for 28 days.","completed","PHIN-214 for Child-Pugh A and B Liver Cirrhosis","This study is testing a new medication called PHIN-214, which is given as a shot under the skin. It's for people with liver cirrhosis (scarring of the liver) classified as Child-Pugh A or B. The main goals are to find out how safe PHIN-214 is, how well people tolerate it, and how the body processes it. Researchers also want to find the best dose, either the highest dose that can be given safely or the dose that works best. PHIN-214 works similarly to another medication called terlipressin, which helps reduce pressure in the liver. This study is currently recruiting participants aged 18 to 75 with a BMI between 18 and 40.","Your safety and how your body processes PHIN-214 will be monitored for up to six weeks after treatment.",111,"Participants will receive PHIN-214 as a single dose in Part 1, or daily doses for up to 28 days in Part 2. The study will measure safety, tolerability, and how your body handles the drug for up to six weeks.","Not stated in the trial record.",[],"v2"]