[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"ReAlta Life Sciences, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":68},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100499048","phase-2-a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-preliminary-efficacy-of-rls-0071-in-newborns-with-moderate-or-severe-hypoxic-ischemic-encephalopathy-undergoing-therapeutic-hypothermia-100499048",false,"NCT05778188","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia","A Phase 2, Two-Stage, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of RLS-0071 in Newborns With Moderate or Severe Hypoxic-Ischemic Encephalopathy Undergoing Therapeutic Hypothermia With Long-Term Follow-Up","STAR","Inclusion Criteria:\n\n1. ≥ 36 weeks gestation.\n2. Sentinel event prior to delivery such as abruption, tight nuchal cord, uterine rupture, profound bradycardia, shoulder dystocia, or cord prolapse or other acute event likely attributable for newborn depression at delivery or an acute change in the fetal status with a clinical presentation consistent with an acute sentinel event with no clearly defined etiology.\n3. Moderate or severe encephalopathy based on at least one risk of encephalopathy criterion (a) and one clinical signs of encephalopathy criterion (b):\n\n   1. Risk of encephalopathy (either):\n\n      * Blood gas drawn within 1 hour of birth, either arterial blood gas (ABG) or venous blood gas (VBG) (cord or infant) with pH ≤ 7.0 OR base deficit ≥ 16 mmol\u002FL.\n\n      OR\n      * appearance, pulse, grimace, activity, and respiration (APGAR) score ≤ 5 at 10 minutes OR\n      * The infant required assisted ventilation ≥ 10 minutes after birth (ie, endotracheal, mask ventilation, or continuous positive airway pressure \\[CPAP\\]).\n   2. Clinical signs of encephalopathy (either\u002Fboth):\n\n      * Moderate\u002FSevere encephalopathy on National Institute of Child Health and Human Development assessment.\n      * Evidence of seizures (clinical and\u002For electroencephalogram).\n4. Be eligible to receive therapeutic hypothermia.\n5. Active whole-body cooling to be started prior to 6 hours of age (passive cooling is permitted prior to active whole body cooling).\n6. Product of a singleton pregnancy.\n7. Written informed consent obtained from parent or legal guardian.\n\nExclusion Criteria:\n\n1. Inability to enroll in the study and initiate the first dose of RLS-0071 within 10 hours of life.\n2. Known major congenital and\u002For chromosomal abnormality(ies).\n3. Severe growth restriction (birth weight ≤ 1800 g).\n4. Prenatal diagnosis of brain abnormality or hydrocephalus.\n5. Patient's head circumference is \\\u003C 30 cm.\n6. 10-minute APGAR score \\\u003C 2, if available.\n7. Infants suspected of overwhelming sepsis or congenital infection based on the Investigator's clinical consideration at the time of enrollment.\n8. Persistent severe hypotension unresponsive to inotropic support (requiring \\>2 inotropes, not inclusive of hydrocortisone).\n9. Persistent severe hypoxia in the setting of 100% fraction of inspired oxygen (FiO₂) and unresponsive to nitric oxide or requiring extracorporeal membrane oxygenation (ECMO).\n10. Severe disseminated intravascular coagulation with clinical bleeding.\n11. Neonatal encephalopathy believed to be due to a cause other than perinatal hypoxia (ie, other than HIE).\n12. Moribund infants for whom withdrawal of care being considered.\n13. Suspected or confirmed fetal alcohol syndrome or suspected substance withdraw seizures.\n14. Any other condition that the investigator may consider would make the patient ineligible for the study or place the patient at an unacceptable risk (Note: this criterion would include a clinically significant \\[eg, Grade 3 or 4\\] intracranial hemorrhage).","ALL","10 Hours",{"count":20,"type":21},70,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Hypoxic-ischemic encephalopathy (HIE) affects approximately 4,000 to 12,000 persons annually in the United States. Mortality from HIE has been reported up to 60%, with at least 25% of survivors left with significant neurocognitive disability. Despite this vital unmet medical need, no pharmacological adjunct or alternative therapy has proven beneficial in improving outcomes in neonatal HIE.\n\nRLS-0071 is a novel peptide being developed for the treatment of neonatal HIE. This study is designed to evaluate the safety and tolerability of RLS-0071 in the treatment of newborns with moderate or severe HIE.",[27],"Hypoxic-Ischemic Encephalopathy",[29,30],"Birth Asphyxia","Anoxic brain injury","RECRUITING","2026-04-07",{"date":34,"type":35},"2026-04-13","ACTUAL",{"date":37,"type":35},"2023-07-27",{"date":39,"type":21},"2028-12",{"name":41,"class":42},"ReAlta Life Sciences, Inc.","INDUSTRY",15,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":67},"100542509","phase-2-safety-pk-pd-dosing-and-efficacy-of-rls-0071for-the-treatment-of-hospitalized-patients-with-steroid-refractory-acute-graft-versus-host-disease-100542509","NCT06343792","Safety, PK, PD, Dosing, and Efficacy of RLS-0071for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease","Phase 2 Open Label Prospective Dose-Ranging Clinical Trial With Escalation and Expansion Cohorts to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the Treatment of Hospitalized Patients With Steroid-Refractory Acute Graft-versus-Host Disease","AURORA","Inclusion Criteria:\n\n* Male or female adults or adolescents (\\>12 years old).\n* Hospitalized with steroid-refractory aGvHD (grade II-IV) after allo-HSCT\n* Anticipated hospital length-of-stay of at least 1 week from the time of RLS-0071 initiation.\n* No plans to add additional GvHD treatment medications or to add, dose-adjust, or discontinue GvHD prophylactic medications during the 7-days of RLS-0071 treatment.\n* Neutrophil recovery following the stem-cell transplantation, defined as blood neutrophil count \\>500\u002FmL for at least 3 consecutive measurements and not supported by growth factor supplementation\n* Weight ≥40 kg and ≤ 140 kg at screening.\n\nExclusion Criteria:\n\n* Has received more than 1 allo-HSCT\n* Current, previous, or planned use of any systemic treatment in addition to or other than corticosteroids or ruxolitinib for aGvHD\n* Previous failure of ruxolitinib treatment\n* Uncontrolled GI infection\n* Endoscopic and biopsy testing (if performed) that definitively rules out lower GI aGvHD\n* Chronic GvHD\n* Participants with evidence of relapsed primary disease, or participants who have been treated for relapse after the allo-HSCT was performed.\n* Unresolved toxicity or complications (other than aGvHD) due to the allo-HSCT\n* Any corticosteroid therapy for indications other than aGvHD at doses of methylprednisolone or equivalent \\>1 mg\u002Fkg per day within 7 days of enrollment.\n* Severe organ dysfunction unrelated to underlying aGvHD\n* Known hypersensitivity, allergy, or anaphylactic reaction to polyethylene glycol (PEG)\n* Significant liver disease that is unrelated to GvHD\n* Severe kidney disease\n* Currently breast feeding.\n* Known pregnancy, a positive pregnancy test at screening, or lactation for WOCBP.\n* Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or human immunodeficiency virus (HIV)-1 or HIV-2.\n* Active sepsis","12 Years",{"count":54,"type":21},66,[24],"This study is a Open Label Prospective Dose-Ranging Escalation and Expansion Trial to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the secondary treatment of acute Graft-versus-Host Disease (aGvHD) in hospitalized patients who are steroid-refractory.",[58],"Steroid Refractory GVHD","2025-11-18",{"date":61,"type":35},"2025-11-24",{"date":63,"type":35},"2024-08-31",{"date":65,"type":21},"2026-12",{"name":41,"class":42},11,""]