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Pant Institute of Postgraduate Medical Education & Research","Delhi","110002","India","IN",{"type":38,"coordinates":39},"Point",[40,41],77.23149,28.65195,{"lat":41,"lon":40},{"facility":44,"status":19,"city":45,"state":19,"zip":19,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":52,"contacts":19},"Haddassah Medical Center","Jerusalem","Israel","IL",{"type":38,"coordinates":49},[50,51],35.21633,31.76904,{"lat":51,"lon":50},{"facility":54,"status":19,"city":55,"state":19,"zip":19,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":62,"contacts":19},"New Zealand Clinical Research","Christchurch","New Zealand","NZ",{"type":38,"coordinates":59},[60,61],172.63333,-43.53333,{"lat":61,"lon":60},{"facility":64,"status":19,"city":65,"state":66,"zip":19,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":73,"contacts":19},"Iatros International","Bloemfontein","Oranage Free State","South Africa","ZA",{"type":38,"coordinates":70},[71,72],26.214,-29.12107,{"lat":72,"lon":71},{"facility":75,"status":19,"city":76,"state":19,"zip":19,"country":77,"countryCode":19,"cosmosGeoPoint":78,"geoPoint":82,"contacts":19},"Ege Universitesi Tip Fakultesi","Izmir","Turkey (Türkiye)",{"type":38,"coordinates":79},[80,81],27.13838,38.41273,{"lat":81,"lon":80},{"type":84,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100652673","phase-3-open-label-phase-3b-study-to-evaluate-the-long-term-efficacy-and-safety-of-lerodalcibep-in-children-and-adolescents-6-to-17-years-of-age-with-heterozygous-familial-hypercholesterolemia-on-stable-diet-and-oral-lipid-lowering-therapy-100652673",false,"NCT07775339","Open Label Phase 3b Study to Evaluate the Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents, 6 to 17 Years of Age, With Heterozygous Familial Hypercholesterolemia on Stable Diet and Oral Lipid-Lowering Therapy","Open Label Phase 3b Study to Evaluate the Long-Term Efficacy and Safety of Lerodalcibep in Children and Adolescents, 6 to 17 Years of Age, With Heterozygous Familial Hypercholesterolemia on Stable Diet and Oral Lipid-Lowering Therapy (LIBerate-Kids OLE)","Inclusion Criteria:\n\nChildren and Adolescents, 6 to 17 Years of Age, with Heterozygous Familial Hypercholesterolemia who completed the LIB00-008 study\n\nExclusion Criteria:\n\nSubjects not completing the LIB00-008 study","ALL","6 Years","17 Years",{"count":96,"type":97},150,"ESTIMATED","INTERVENTIONAL",[100],"PHASE3","The goal is to assess the long term efficacy (LDL cholesterol reduction) and safety over 3 years of lerodalcibep (Lerochol) SC 300 mg QM administered by auto-injector (AI)\u002Fpre-filled pen (PFP) in male and female pediatric patients 6 to 17 years of age, with inherited high cholesterol (HeFH) on a stable diet and maximally tolerated oral LDL C lowering drug therapy such as statins who completed the 24 week placebo controlled base trial.\n\nThe main question\\[s\\] it aims to answer are:\n\nHow effective is Lerochol in maintaining LDL cholesterol reductions over years? How well is it tolerated and are there any safety concerns?\n\nParticipants will visit the clinic every month for 3 months and then home dosed with clinic visits every 3 months. They will undergo periodic physical exams, height and weight measurements, answer questions, have blood drawn from a vein in their arm, have blood pressure measurements, EKC heart tests, and receive monthly injections lasting about 5 seconds in their arms or abdomen with an autoinjector.",[103],"Heterozygous Familial Hypercholesterolemia (HeFH)",[105,106,107,108,109],"PCSK9 inhibitor","LDL-C","HeFH","lerodalcibep","pediatric","NOT_YET_RECRUITING","2026-08-16",{"date":113,"type":114},"2026-08-20","ACTUAL",{"date":116,"type":97},"2027-01-20",{"date":118,"type":97},"2031-12-31",{"name":5,"class":6},5]