[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"heterozygous-or-homozygous-familial-hypercholesterolemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:heterozygous-or-homozygous-familial-hypercholesterolemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100491688","phase-3-long-term-safety-and-tolerability-of-inclisiran-in-participants-with-hefh-or-hofh-who-have-completed-the-pediatric-orion-16-orion-13-orion-20-or-orion-19-studies-100491688",false,"NCT05682378","Long-term Safety and Tolerability of Inclisiran in Participants With HeFH or HoFH Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20, or ORION-19 Studies","An Open-label, Single Arm, Multicenter Extension Study to Evaluate Long-term Safety and Tolerability of Inclisiran in Participants With Heterozygous or Homozygous Familial Hypercholesterolemia Who Have Completed the Pediatric ORION-16, ORION-13, ORION-20 or ORION-19 Studies (VICTORION-PEDS-OLE)","V-PEDS-OLE","Key inclusion:\n\n* Male and female participants with a diagnosis of HeFH or HoFH who completed the ORION-16, ORION-13, ORION-20 or ORION-19 studies\n* Per investigator's clinical judgment, participant derived benefit from treatment with inclisiran in the ORION-16, ORION-13, ORION-20 or ORION-19 studies\n\nKey exclusion:\n\n* Participants who in the feeder ORION-16, ORION-13, ORION-20, or ORION-19 studies either screen failed or permanently discontinued from the treatment\u002Fstudy for any reason or had serious safety or tolerability issues related to inclisiran treatment\n* Any uncontrolled or serious disease, or any medical, physical, or surgical condition, that may either interfere with participation in the clinical study or interpretation of clinical study results, and\u002For put the participant at significant risk","ALL","12 Years","100 Years",{"count":21,"type":22},195,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of this open-label, single arm, multicenter extension study is to evaluate the long-term safety and tolerability of inclisiran in participants with HeFH or HoFH who have completed the ORION-16 (CKJX839C12301), ORION-13 (CKJX839C12302), ORION-20 (CKJX839C12303) or ORION-19 (CKJX839C12304) studies.",[28],"Heterozygous or Homozygous Familial Hypercholesterolemia",[30,31,32,33,34,35,36],"KJX839","heterozygous familial hypercholesterolemia","homozygous familial hypercholesterolemia","familial hypercholesterolemia","FH","inclisiran","pediatric","RECRUITING","2026-05-13",{"date":40,"type":41},"2026-05-15","ACTUAL",{"date":43,"type":41},"2023-02-10",{"date":45,"type":22},"2032-03-28",{"name":47,"class":48},"Novartis Pharmaceuticals","INDUSTRY",52]