[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478774":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":46,"responsibleParty":106,"collaborators":44,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":44,"eligibilityCriteria":114,"healthyVolunteers":110,"sex":115,"minAge":44,"maxAge":44,"enrollmentInfo":116,"targetDuration":44,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":49,"whyStopped":44,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Pharmazz, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Normal Saline + Standard of care","ACTIVE_COMPARATOR","Patients will receive the best available standard of care. Normal saline will be administered as an intravenous bolus over one minute every 3 hours on day 1, day 3, and day 6 post randomizations.",[13],"Drug: Normal Saline along with standard treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Sovateltide + Standard of care","EXPERIMENTAL","Patients will receive the best available standard of care. Dose of sovateltide (0.3 µg\u002Fkg) will be administered as an intravenous bolus over one minute every 3 hours on day 1, day 3, and day 6 post randomizations.",[19],"Drug: Sovateltide along with standard treatment",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Normal Saline along with standard treatment","Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm normal saline along with standard treatment will be given for active comparison.",[9],[27],"Vehicle",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Sovateltide along with standard treatment","Sovateltide is an endothelin-B receptor agonist. It has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in hypoxic-ischemic encephalopathy patients. In this arm sovateltide along with standard treatment will be given for active comparison.",[15],[33],"PMZ-1620",[35],{"name":36,"affiliation":37,"role":38},"Anil Gulati","Chairman and CEO","STUDY_CHAIR",[40],{"name":41,"role":42,"phone":43,"phoneExt":44,"email":45},"Manish S Lavhale","CONTACT","+91 9873847397",null,"manish.lavhale@pharmazz.com",[47,65,79,93],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Father Muller Medical College Hospital","RECRUITING","Mangalore","Karnataka","575002","India","IN",{"type":56,"coordinates":57},"Point",[58,59],74.85603,12.91723,{"lat":59,"lon":58},[62],{"name":63,"role":42,"phone":44,"phoneExt":44,"email":64},"Pavan Hedge","pavanhegde@hotmail.co",{"facility":66,"status":49,"city":67,"state":68,"zip":69,"country":53,"countryCode":54,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Christian Medical College and Hospital","Ludhiana","Punjab","141008",{"type":56,"coordinates":71},[72,73],75.85379,30.91204,{"lat":73,"lon":72},[76],{"name":77,"role":42,"phone":44,"phoneExt":44,"email":78},"Gurmeet Kaur","navgur@gmail.com",{"facility":80,"status":81,"city":82,"state":83,"zip":84,"country":53,"countryCode":54,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Niloufer Hospital","NOT_YET_RECRUITING","Hyderabad","Telangana","500 004",{"type":56,"coordinates":86},[87,88],78.45636,17.38405,{"lat":88,"lon":87},[91],{"name":92,"role":42,"phone":44,"phoneExt":44,"email":44},"Swapna Lingaldinna",{"facility":94,"status":81,"city":95,"state":96,"zip":97,"country":53,"countryCode":54,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"GSVM Medical College","Kanpur","Uttar Pradesh","208002",{"type":56,"coordinates":99},[100,101],80.34975,26.46523,{"lat":101,"lon":100},[104],{"name":105,"role":42,"phone":44,"phoneExt":44,"email":44},"Yashwant K Rao",{"type":107,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100478774","phase-2-assess-safety-and-efficacy-of-sovateltide-in-hypoxic-ischemic-encephalopathy-100478774",false,"NCT05514340","Assess Safety and Efficacy of Sovateltide in Hypoxic-ischemic Encephalopathy","A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase-II Trial to Assess Safety, and Efficacy of Sovateltide in the Treatment of Hypoxic-ischemic Encephalopathy in Neonates","Inclusion Criteria:\n\n1. Either sex with ≥ 36 weeks of gestational age\n2. Receiving supportive management for perinatal asphyxia\n3. Perinatal depression, based on at least one of the following:\n\n   * Apgar score of \\\u003C5 at 10 minutes\n   * Need for resuscitation (chest compressions or mechanical ventilation) at birth\n   * pH \\\u003C7.00 or base deficit ≥ 16 mmol\u002Fliter in the cord or arterial blood within 60 minutes of birth\n   * Moderate\u002Fsevere encephalopathy evident by at least 3 of 6 modified Sarnat criteria, present between 1 to 6 hours of birth.\n4. Informed consent by one of the parents or a legal representative\n\nExclusion Criteria:\n\n1. Gestational age \\\u003C36 weeks\n2. Admitted to hospital 12-hours after birth\n3. A genetic or congenital condition that affects neuronal development\n4. TORCH infection\n5. Neonatal sepsis\n6. Complex congenital heart disease\n7. Severe dysmorphic feature\n8. Microcephaly (head circumference \\\u003C 2 Standard Deviations below mean for gestational age)","ALL",{"count":117,"type":118},40,"ESTIMATED","INTERVENTIONAL",[121],"PHASE2","Sovateltide (PMZ-1620; IRL-1620) is targeted to be used as a \"Treatment for hypoxic-ischemic encephalopathy in neonates,\" which is a life-threatening condition. Sovateltide augments neuronal progenitor cell differentiation and better mitochondrial morphology and biogenesis to activate a regenerative response in the central nervous system. The only treatment for HIE is therapeutic hypothermia with limited success, and studies indicate that sovateltide may be beneficial in these patients.",[124,125,126],"Hypoxic-Ischemic Encephalopathy","Neonatal Asphyxia","Neonatal Encephalopathy",[124,128,126],"Cerebral Asphyxia","2025-12-26",{"date":131,"type":132},"2025-12-31","ACTUAL",{"date":134,"type":132},"2023-09-06",{"date":136,"type":118},"2026-12",{"name":5,"class":6},4]