[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"children-under-2-years\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:children-under-2-years":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,40],{"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":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100508435","a-study-to-observe-the-pattern-of-use-and-safety-of-rivaroxaban-in-children-under-2-years-old-with-venous-thromboembolism-vte-100508435",false,"NCT05900388","A Study to Observe the Pattern of Use and Safety of Rivaroxaban in Children Under 2 Years Old With Venous Thromboembolism (VTE)","Xarelto Paediatric VTE PASS Drug Utilization Study: An Observational, Longitudinal, Multi-source Drug Utilization Safety Study to Evaluate the Drug Use Patterns and Safety of Rivaroxaban Oral Suspension in Children Under Two Years With Venous Thromboembolism","XAPAEDUS","Inclusion Criteria:\n\n* Evidence of initiation of an anticoagulant therapy (index drug), either rivaroxaban oral suspension or other anticoagulation therapies (heparins, Vitamin K antagonists (VKAs), other Direct oral anticoagulants (DOACs)). Initiation will be defined as a first record of any anticoagulation therapy (rivaroxaban or SOC) without any anticoagulation therapy in the previous 6 months, or since date of birth for children less than 6 months\n* Evidence of a prior VTE diagnosis (index VTE), defined as the presence of at least one primary\u002Fmain or secondary diagnosis code for VTE recorded in inpatient setting in the previous 30 days\n* Age less than two years on index date.\n* Baseline period for availability of patient data history in the data source. A minimal baseline period of six months before index date for children aged between six months and two years, and a baseline period since birth for children less than six months of age will be required.\n\nExclusion Criteria:\n\n\\- None","ALL","2 Years",{"count":20,"type":21},850,"ESTIMATED","OBSERVATIONAL","This is an observational study in which only data are collected from participants receiving their usual treatment. The study is done in children under 2 years old with venous thromboembolism (VTE).\n\nVTE is a condition in which blood clots form in the veins, usually in the leg. This can cause pain and swelling. The clot can also break apart and travel in the blood to the lungs where it can block the blood flow. This can be life threatening.\n\nRivaroxaban is approved for doctors to prescribe to children with VTE, but there is limited information about how it is used, how well it works, and how safe it is in children under 2 years old. Children in this study are already receiving or will receive rivaroxaban or other currently used medicines for VTE from their doctor according to the approved product information.\n\nThe purpose of this study is to collect information on the pattern of use and safety of rivaroxaban and other standard medicines for VTE in children under 2 years old.\n\nThe main information that researchers will collect in this study:\n\n* Age, gender, and other information about the child and their illness\n* Type of VTE treatment given to the child\n* Occurrence of medically important bleeding and its severity\n\nFurther information that researchers will collect:\n\n* Changes in the characteristics of the children given VTE treatment (e.g., changes in the age range of children given VTE treatment) and changes in the treatment pattern for VTE\n* Return of VTE symptoms\n* Types of doctors who prescribe VTE treatment and their set-up (e.g., special clinics versus hospitals) Besides this data collection, no further tests or examinations are needed in this study.\n\nThe data for this study will be collected from electronic health records and health insurance claims data until 2026.\n\nResearchers will observe each child during treatment until:\n\n* end of the anticoagulation treatment period e.g. discontinuation of all study drugs,\n* their information is no longer available, or\n* the study ends.",[25,26],"Venous Thromboembolism","Children Under 2 Years","NOT_YET_RECRUITING","2026-06-18",{"date":30,"type":31},"2026-06-22","ACTUAL",{"date":33,"type":21},"2026-09-01",{"date":35,"type":21},"2029-06-30",{"name":37,"class":38},"Bayer","INDUSTRY",4,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100562075","phase-4-assessment-of-safety-of-the-use-of-fenfluramine-in-children-with-dravet-syndrome-under-24-months-of-age-100562075","NCT06598449","Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age","Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under the Age of 24 Months","Inclusion Criteria:\n\nTreating physicians must submit a clinical statement of potential benefit, which includes patient's gender, age, diagnosis, genetic pathogenic variant, co-morbidities, seizure history, prior and current therapies, response to prior therapies and reason for request. Echocardiogram (ECHO) results must also be submitted to the lead site prior to final approval. Patients must be between 12 and 23 months old to be eligible. Additional inclusion criteria:\n\n1. SCN1A with a known or presumed pathogenic variant or VUS with a history of prolonged seizure or a clinical diagnosis of Dravet syndrome.\n2. Failure of at least one anti-seizure medication that is not a sodium channel blocker (lamotrigine, oxcarbazepine, carbamazepine, eslicarbazepine)\n\nExclusion Criteria:\n\n1. Patients with mild or greater mitral valve regurgitation and\u002For trace or greater aortic valve regurgitation will not be eligible for participation. The clinical statement can be submitted first for initial, conditional approval and then ECHO results can be submitted at a later date for final approval.\n2. Patients with failure to thrive will not be eligible for participation as fenfluramine can suppress appetite and has a risk for weight loss. Failure to thrive will be evaluated on the following criteria:\n\n   1. Weight less than the 2nd percentile.\n   2. Lack of weight gain that crosses two or more of the major percentile lines and is not congruent with length.","12 Months","24 Months",{"count":50,"type":21},5,"INTERVENTIONAL",[53],"PHASE4","Dravet syndrome is a genetic epilepsy associated with pathogenic variants in SCN1A that codes for Nav1.1, a protein necessary for sodium channels. Children with Dravet syndrome classically present in the first year of life with prolonged seizures, often hemiclonic and in the setting of fever or temperature changes such as getting in or out of bath water. Many anti-seizure medications are sodium channel blockers and exacerbate seizures in this patient population. This creates some limitations in medication choices for this patient population. Recently fenfluramine was approved for use in Dravet syndrome for people 2 years and older. Randomized studies demonstrated a 74.9% reduction of convulsive motor seizures compared to 19.2% in the placebo group. Additionally, 16% of children treated with fenfluramine were seizure free. Fenfluramine is likely to be as effective in children under the age of 2 years. The current study has proposed an intermediate size patient population expanded access protocol to allow access to fenfluramine for children under 24 months of age.",[56,26],"Dravet Syndrome (DS)",[58,59,60],"Fenfluramine","Dravet Syndrome","Children under 2 years","RECRUITING","2026-05-13",{"date":64,"type":31},"2026-05-15",{"date":66,"type":31},"2024-10-22",{"date":68,"type":21},"2027-07",{"name":70,"class":71},"University of Colorado, Denver","OTHER",1]