[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540353":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":33,"locations":43,"responsibleParty":207,"collaborators":209,"id":212,"slug":213,"hasResults":214,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":214,"sex":220,"minAge":221,"maxAge":222,"enrollmentInfo":223,"targetDuration":32,"studyType":226,"phases":227,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":46,"whyStopped":32,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":243},{"fullName":5,"class":6},"Noveome Biotherapeutics, formerly Stemnion","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1 - lower dose active + SOC treatment vs. SOC alone in higher weight range","OTHER","Infants with weight at diagnosis of NEC ≥1000 g and ≤3000 g; 0.5 mL\u002Fkg of ST266, QD, + Standard of Care (SOC) treatment (n=6); SOC (n=3)",[13],"Biological: ST266",{"label":15,"type":10,"description":16,"interventionNames":17},"Cohort 2 - higher dose active + SOC treatment vs. SOC alone in higher weight range","Infants with weight at diagnosis of NEC ≥1000 g and ≤3000 g; 1.0 mL\u002Fkg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3 - lower dose active + SOC treatment vs. SOC alone in lower weight range","Infants with weight at diagnosis of NEC ≥500 g and ≤999 g; 0.5 mL\u002Fkg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)",[13],{"label":23,"type":10,"description":24,"interventionNames":25},"Cohort 4 - higher dose active + SOC treatment vs. SOC alone in lower weight range","Infants with weight at diagnosis of NEC ≥500 g and ≤999 g; 1.0 mL\u002Fkg of ST266, QD; + Standard of Care (SOC) treatment (n=6); SOC (n=3)",[13],[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"BIOLOGICAL","ST266","Patients randomized to investigative drug product (ST266) will receive either 0.5 mL\u002Fkg or 1.0 mL\u002Fkg of ST266 QD in addition to Standard of Care treatment; Patients randomized to SOC will receive standard of care treatment only.",[9,15,19,23],null,[34,39],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Karin Potoka, MD","CONTACT","412-512-1446","kpotoka@noveome.com",{"name":40,"role":36,"phone":41,"phoneExt":32,"email":42},"Shawna M Rose, BS","513-205-1091","srose@noveome.com",[44,68,79,101,119,139,160,186],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Arkansas Children's Hospital","RECRUITING","Little Rock","Arkansas","72202","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-92.28959,34.74648,{"lat":56,"lon":55},[59,63,65],{"name":60,"role":36,"phone":61,"phoneExt":32,"email":62},"Vikas Chowdhary, MD","501-364-1028","vchowdhary@uams.edu",{"name":60,"role":64,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"name":66,"role":67,"phone":32,"phoneExt":32,"email":32},"Sherry Courtney, MD","SUB_INVESTIGATOR",{"facility":69,"status":46,"city":47,"state":48,"zip":70,"country":50,"countryCode":51,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"University of Arkansas for Medical Sciences","72205",{"type":53,"coordinates":72},[55,56],{"lat":56,"lon":55},[75,77,78],{"name":60,"role":36,"phone":76,"phoneExt":32,"email":62},"848-702-3188",{"name":60,"role":64,"phone":32,"phoneExt":32,"email":32},{"name":66,"role":67,"phone":32,"phoneExt":32,"email":32},{"facility":80,"status":46,"city":81,"state":82,"zip":83,"country":50,"countryCode":51,"cosmosGeoPoint":84,"geoPoint":88,"contacts":89},"Yale-New Haven Hospital","New Haven","Connecticut","06510",{"type":53,"coordinates":85},[86,87],-72.92816,41.30815,{"lat":87,"lon":86},[90,94,95,97,99],{"name":91,"role":36,"phone":92,"phoneExt":32,"email":93},"Sarah Taylor, MD","203-688-2320","sarah.n.taylor@yale.edu",{"name":91,"role":64,"phone":32,"phoneExt":32,"email":32},{"name":96,"role":67,"phone":32,"phoneExt":32,"email":32},"Kathryn Fletcher, MD",{"name":98,"role":67,"phone":32,"phoneExt":32,"email":32},"Samuel Gentle, MD",{"name":100,"role":67,"phone":32,"phoneExt":32,"email":32},"Catherine Buck, MD",{"facility":102,"status":46,"city":103,"state":104,"zip":105,"country":50,"countryCode":51,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"BayCare Health System-St. Joseph's Women's Hospital","Tampa","Florida","33607",{"type":53,"coordinates":107},[108,109],-82.45843,27.94752,{"lat":109,"lon":108},[112,116,117],{"name":113,"role":36,"phone":114,"phoneExt":32,"email":115},"Jenelle Ferry, MD","813-872-2924","jenelle.ferry@baycare.org",{"name":113,"role":64,"phone":32,"phoneExt":32,"email":32},{"name":118,"role":67,"phone":32,"phoneExt":32,"email":32},"Monisha Saste, MD",{"facility":120,"status":46,"city":121,"state":122,"zip":123,"country":50,"countryCode":51,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"NorthShore University-Evanston Hospital","Evanston","Illinois","60201",{"type":53,"coordinates":125},[126,127],-87.69006,42.04114,{"lat":127,"lon":126},[130,134,135,137],{"name":131,"role":36,"phone":132,"phoneExt":32,"email":133},"Brandy Frost, MD","773-562-7420","bfrost@northshore.org",{"name":131,"role":64,"phone":32,"phoneExt":32,"email":32},{"name":136,"role":67,"phone":32,"phoneExt":32,"email":32},"Michael Caplan, MD",{"name":138,"role":67,"phone":32,"phoneExt":32,"email":32},"Matthew Derrick, MD",{"facility":140,"status":46,"city":141,"state":142,"zip":143,"country":50,"countryCode":51,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Oklahoma Children's Hospital","Oklahoma City","Oklahoma","73104",{"type":53,"coordinates":145},[146,147],-97.51643,35.46756,{"lat":147,"lon":146},[150,155,156,158],{"name":151,"role":36,"phone":152,"phoneExt":153,"email":154},"Hala Chaaban, MD","405-271-5215","42063","hala-chaaban@ouhsc.edu",{"name":151,"role":64,"phone":32,"phoneExt":32,"email":32},{"name":157,"role":67,"phone":32,"phoneExt":32,"email":32},"Pratibha Thakkar, MD",{"name":159,"role":67,"phone":32,"phoneExt":32,"email":32},"Catherine Hunter, MD",{"facility":161,"status":46,"city":162,"state":163,"zip":164,"country":50,"countryCode":51,"cosmosGeoPoint":165,"geoPoint":169,"contacts":170},"Penn State Health Milton S Hershey Medical Center\u002FPenn State University College of Medicine","Hershey","Pennsylvania","17033",{"type":53,"coordinates":166},[167,168],-76.65025,40.28592,{"lat":168,"lon":167},[171,175,176,178,180,182,184],{"name":172,"role":36,"phone":173,"phoneExt":32,"email":174},"Timothy Palmer, MD","717-531-8413","tpalmer@pennstatehealth.psu.edu",{"name":172,"role":64,"phone":32,"phoneExt":32,"email":32},{"name":177,"role":67,"phone":32,"phoneExt":32,"email":32},"Shaili Amatya, MD",{"name":179,"role":67,"phone":32,"phoneExt":32,"email":32},"Tammy Corr, DO",{"name":181,"role":67,"phone":32,"phoneExt":32,"email":32},"Chintan Gandhi, MD",{"name":183,"role":67,"phone":32,"phoneExt":32,"email":32},"Sarah Mahdally, DO",{"name":185,"role":67,"phone":32,"phoneExt":32,"email":32},"Sara Mola, MD",{"facility":187,"status":46,"city":188,"state":163,"zip":189,"country":50,"countryCode":51,"cosmosGeoPoint":190,"geoPoint":194,"contacts":195},"University of Pittsburgh Medical Center Magee Womens Hospital","Pittsburgh","15219",{"type":53,"coordinates":191},[192,193],-79.99589,40.44062,{"lat":193,"lon":192},[196,200,201,203,205],{"name":197,"role":36,"phone":198,"phoneExt":32,"email":199},"Toby Yanowitz, MD","412-641-6260","yanotd@upmc.edu",{"name":197,"role":64,"phone":32,"phoneExt":32,"email":32},{"name":202,"role":67,"phone":32,"phoneExt":32,"email":32},"Nicole Dobson, MD",{"name":204,"role":67,"phone":32,"phoneExt":32,"email":32},"Brighid O'Donnell, MD",{"name":206,"role":67,"phone":32,"phoneExt":32,"email":32},"Abeer Azzuqa, MD",{"type":208,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[210],{"name":211,"class":6},"Parexel","100540353","phase-1-study-to-assess-the-safety-tolerability-and-preliminary-efficacy-of-st266-in-infants-with-necrotizing-enterocolitis-nec-100540353",false,"NCT06315738","Study to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)","Randomized, Controlled, Phase 1-2 Open Label Study of ST266 IV Administration to Assess the Safety, Tolerability, and Preliminary Efficacy of ST266 in Infants With Necrotizing Enterocolitis (NEC)","NEC","Inclusion Criteria:\n\n1. Infants born from ≥22 weeks gestational age up to and including 40 weeks gestational age; up to 40 weeks postmenstrual age (gestational age plus chronological age in terms of weeks) with current weight at diagnosis of NEC between ≥500g and ≤3000g, as a result of prematurity and\u002For IUGR. Parent(s)\u002Flegal medical representative(s) voluntarily provides written consent prior to study enrollment.\n2. Bell's Stage IIA or higher medical NEC (Stages IIA - IIIA only) diagnosis by radiologic confirmed pneumatosis intestinalis and may include intestinal dilation and ileus. The clinician confirms NEC diagnosis by evaluation of the radiologic imaging for confirmed pneumatosis intestinalis. If X-ray is used and is equivocal, an ultrasound (US) may be used, if available, to confirm pneumatosis. If the clinician (Neonatologist and\u002For Pediatric Surgeon) has differing interpretation from that of the Radiologist, that should be documented in both the medical and research records for accuracy of NEC diagnosis.\n\nExclusion Criteria:\n\n1. Infants with abdominal perforation.\n2. Not expected to survive ≥2 weeks or born with a lethal condition requiring hospice or palliative care (e.g., disease has progressed to NEC totalis, or patient has multi-organ system failure).\n3. Born with major congenital anomalies such as cardiac defects (e.g., Tetralogy of Fallot) or chromosomal disorders\u002Fanomalies (e.g., neural tube defect).\n4. Mother's receipt of any investigational product during pregnancy.\n5. Infants with malignancies (e.g., neoplastic cell growth as a solid tumor or a blood neoplasm, such as congenital leukemia).\n6. Infants with hypercoagulability disorders (any active thrombosis, diagnosis of disseminated intravascular coagulation or other acquired\u002Finherited disorders (i.e., hemophilia) of coagulation.\n7. Infants with a known immunodeficiency (such as galactosemia or agranulocytosis).\n8. Infants with anatomic defects that require surgical intervention.\n9. Infants with persistent pulmonary hypertension of newborn.\n10. Infants with any congenital or acquired gastrointestinal pathology that preclude feeds within 7 days after birth (e.g., duodenal atresia).\n11. Infants who have hypoxic ischemic injury (perinatal asphyxia).\n12. Infants with polycythemia (at time of treatment) (\\>22 g\u002FdL).\n13. Positive maternal human immunodeficiency virus status.\n14. History of maternal drug abuse (such as amphetamines, opiates, cocaine). This does not include marijuana, or prescription medications for treatment of drug abuse.\n15. Considered by the Investigator, for any reason, to be an unsuitable candidate for the study.\n16. Infants diagnosed with NEC who will require immediate surgical intervention.","ALL","2 Weeks","8 Weeks",{"count":224,"type":225},36,"ESTIMATED","INTERVENTIONAL",[228,229],"PHASE1","PHASE2","The primary objective of this study is to determine the safety and tolerability of two dose levels (0.5 mL\u002Fkg and 1.0 mL\u002Fkg) of once daily (QD) via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC by incidence of treatment emergent adverse events (TEAEs) and SAEs, with a secondary objective to assess preliminary efficacy of the same two dose levels (0.5 mL\u002Fkg and 1.0 mL\u002Fkg) of QD via IV route of administration of ST266 in treating patients with Bell's stage IIA or higher medical NEC.",[232],"Necrotizing Enterocolitis",[232,218],"2026-04-07",{"date":236,"type":237},"2026-04-13","ACTUAL",{"date":239,"type":237},"2024-08-19",{"date":241,"type":225},"2029-11",{"name":5,"class":6},8]