[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"familial-hypercholesterolemia---heterozygous\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:familial-hypercholesterolemia---heterozygous":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,59],{"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":46,"whyStopped":4,"lastUpdateSubmitDate":47,"lastUpdatePostDateStruct":48,"startDateStruct":51,"completionDateStruct":53,"leadSponsor":55,"locationsCount":58},"100561965","phase-3-study-to-evaluate-efficacy-and-safety-of-inclisiran-in-children-with-heterozygous-familial-hypercholesterolemia-100561965",false,"NCT06597019","Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia","Two Part (Double-blind Inclisiran Versus Placebo [Year 1] Followed by Open-label Inclisiran [Year 2]) Randomized Multicenter Study to Evaluate Safety, Tolerability and Efficacy of Inclisiran in Children (6 to Less Than 12 Years) With Heterozygous Familial Hypercholesterolemia and Elevated LDL- Cholesterol","ORION-20","Inclusion Criteria:\n\n* Male or female participants, 6 to \\\u003C12 years of age at screening\n* HeFH diagnosed either by genetic testing or on phenotypic criteria\n* Fasting LDL-C \\>130 mg\u002FdL (3.4 mmol\u002FL) at screening\n* For participants 8 to \\\u003C12 years, on an optimal dose of statin (investigator's discretion) unless statin intolerant, with or without other lipid-lowering therapy (e.g. ezetimibe). For participants \\\u003C8 years, the use of background lipid-lowering treatment is based on investigator's discretion.\n* Participants on lipid-lowering therapies (such as statin and\u002For e.g. ezetimibe) must be on a stable dose for ≥30 days before screening with no planned medication or dose changes during study participation.\n\nExclusion Criteria:\n\n* Previous treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9\n* Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome\n* Homozygous familial hypercholesterolemia (HoFH)\n* Body weight \\\u003C16 kg at the screening and\u002For randomization (Day 1) visit\n* Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained alanine aminotransferase (ALT), aspartate aminotransferase (AST) elevation \\>3x ULN, or total bilirubin elevation \\>2x ULN (except patients with Gilbert's syndrome)\n* Pregnant or nursing females\n* Recent and\u002For planned use of other investigational medicinal products or devices","ALL","6 Years","11 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to \\\u003C12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein cholesterol (LDLC).",[28],"Familial Hypercholesterolemia - Heterozygous",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"Heterozygous familial hypercholesterolemia (HeFH),","LDL-cholesterol (LDL-C),","Children,","pediatric,","small interfering ribonucleic acid (siRNA),","inclisiran,","Familial Hypercholesterolemia,","Heterozygous FH,","Hypercholesterolemia,","Lipoprotein(a),","Hyperlipidemia,","Dyslipidemia,","Heart Failure,","Cardiovascular Diseases,","Cholesterol,","Aortic Stenosis","RECRUITING","2026-05-13",{"date":49,"type":50},"2026-05-15","ACTUAL",{"date":52,"type":50},"2024-12-09",{"date":54,"type":22},"2029-04-15",{"name":56,"class":57},"Novartis Pharmaceuticals","INDUSTRY",66,{"id":60,"slug":61,"hasResults":11,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":11,"sex":17,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":4,"studyType":71,"phases":4,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":46,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":5},"100390972","early-detection-of-familial-hypercholesterolemia-in-children-100390972","NCT04370899","Early Detection of Familial Hypercholesterolemia in Children","Early Detection of Familial Hypercholesterolemia in Children in Tarragona Province","DECOPIN","Inclusion Criteria:\n\n* Children between 2 and 18 years of age.\n* LDL-C level above 135 mg\u002FdL\n* Previously, the pediatrician will have discarded secondary causes (hypercholesterolaemia such as hypothyroidism, nephrotic syndrome, diabetes, renal insufficiency).\n\nAfter confirmation that one of the parents has a genetic mutation (Lipoxip\u002FLiponext) or clinical diagnosis (DLCN ≥ 8), the child will be studied. The progenitor with hypercholesterolemia will be considered as an index case, in this way we will demonstrate the vertical transmission of the genetic disease.\n\nExclusion Criteria:\n\n* The child population under 2 and over the age of 18 and children.\n* Children with high cholesterol but by secondary causes.","2 Years","18 Years",{"count":70,"type":22},400,"OBSERVATIONAL","Heterozigous FH is an underdiagnosed disease in the paediatric population. Its early detection, would allow us to initiate lifestyle therapeutical changes and early pharmacological therapy if necessary. This is a key fact to reduce atherosclerosis progression and cardiovascular risk in adulthood. Moreover, it will allow, detecting the first and second degree affected relatives.",[74,28,75],"Familial Hypercholesterolemia","Familial Hypercholesterolemia - Homozygous",[74,77,78,79,80,81],"Childhood","cardiovascular risk","lifestyle assessment","genetic disorder","LDL cholesterol","2025-04-17",{"date":84,"type":50},"2025-04-18",{"date":86,"type":50},"2013-03-14",{"date":88,"type":22},"2030-07-01",{"name":90,"class":91},"Institut Investigacio Sanitaria Pere Virgili","OTHER"]