[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616696":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":25,"locations":25,"responsibleParty":26,"collaborators":25,"id":30,"slug":31,"hasResults":32,"nctId":33,"briefTitle":34,"officialTitle":35,"acronym":25,"eligibilityCriteria":36,"healthyVolunteers":32,"sex":37,"minAge":38,"maxAge":25,"enrollmentInfo":39,"targetDuration":25,"studyType":42,"phases":43,"briefSummary":45,"conditions":46,"keywords":50,"overallStatus":55,"whyStopped":25,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":25},{"fullName":5,"class":6},"Sheba Medical Center","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","ACTIVE_COMPARATOR","Participants in this arm will receive the full standard-of-care course of Teprotumumab. This consists of a total of 8 intravenous (IV) infusions.",[13],"Drug: Teprotumumab Injection [Tepezza]",{"label":15,"type":16,"description":17,"interventionNames":18},"Shortened Treatment","EXPERIMENTAL","Participants in this arm will receive a shortened course of Teprotumumab. After demonstrating an \"Early Optimal Clinical Response\" following the first 4 infusions, treatment will be discontinued. These participants will receive a total of 4 intravenous (IV) infusions instead of the standard 8.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Teprotumumab Injection [Tepezza]","As a standard of care Teprotumumab is administered intravenously every 3 weeks for a total of 8 infusions (24 weeks).\n\nIn the Shortened Arm participants receive a total of 4 infusions (12 weeks) provided they met the \"Early Optimal Clinical Response\" criteria at Week 12.",[15,9],null,{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Prof. Landau Prat Daphna","Oculoplastic and Orbital surgeon","100616696","phase-4-comparison-of-the-efficacy-and-safety-of-4-vs-8-treatments-with-tepezza-teprotumumab-for-thyroid-eye-disease-100616696",false,"NCT07308964","Comparison of the Efficacy and Safety of 4 vs. 8 Treatments With Tepezza (Teprotumumab) for Thyroid Eye Disease","A Comparative Study of Shortened (4-Infusion) Versus Standard (8-Infusion) Teprotumumab Regimens in Patients With Thyroid Eye Disease (TED) Exhibiting an Early Optimal Clinical Response","Inclusion Criteria:\n\n* Participants must have a confirmed diagnosis of active Thyroid Eye Disease (TED).\n* Participants must be eligible for and have started the standard Teprotumumab (Tepezza) treatment protocol.\n* Participants must demonstrate a significant clinical response by the 4th infusion.\n* Ability to understand and provide signed written informed consent.\n\nExclusion Criteria:\n\n* Previous use of Teprotumumab or other biologic therapies for TED.\n* Participants who do not show early clinical response after the 4th infusion.\n* Participants who have any medical contraindications to Teprotumumab or any of its components.\n* Participants who have any known hearing problems.","ALL","18 Years",{"count":40,"type":41},40,"ESTIMATED","INTERVENTIONAL",[44],"PHASE4","The goal of this interventional study is to compare the clinical outcomes of shortened 4-infusion course versus the standard 8-infusion course of Teprotumumab (Tepezza) in patients with active Thyroid Eye Disease (TED).\n\nThe main question it aims to answer is:\n\n\\* Is a shorter course equally effective and safe for patients who respond well early in treatment.\n\nParticipants who demonstrate an early clinical response as part of their treatment with Teprotumumab will receive a shorter protocol of 4 infusions instead of the standard 8.",[47,48,49],"Thyroid Eye Disease","Thyroid Eye Disease, TED","Thyroid Eye Disease (TED)",[51,52,53,54],"thyroid eye disease","TED","Tepezza","Teprotumumab","NOT_YET_RECRUITING","2025-12-28",{"date":58,"type":59},"2025-12-30","ACTUAL",{"date":61,"type":41},"2026-01",{"date":63,"type":41},"2028-05",{"name":5,"class":6}]