[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642347":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":30,"centralContacts":34,"locations":38,"responsibleParty":42,"collaborators":38,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":38,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":71,"whyStopped":38,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":38},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Ianalumab + eltrombopag","EXPERIMENTAL","Participants will receive ianalumab in addition to eltrombopag.",[13,14],"Biological: Ianalumab","Drug: Eltrombopag",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"BIOLOGICAL","Ianalumab","Liquid in a vial Concentrate for solution for infusion",[9],[22],"VAY736",{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Eltrombopag","Film-coated tablet and also Powder for oral suspension",[9],[29],"ETB115",[31],{"name":32,"affiliation":32,"role":33},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[35,40],{"name":32,"role":36,"phone":37,"phoneExt":38,"email":39},"CONTACT","1-888-669-6682",null,"novartis.email@novartis.com",{"name":32,"role":36,"phone":41,"phoneExt":38,"email":38},"+41613241111",{"type":43,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR","100642347","phase-2-a-study-of-ianalumab-in-addition-to-eltrombopag-in-pediatric-patients-with-primary-itp-who-failed-corticosteroids-100642347",false,"NCT07660172","A Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary ITP Who Failed Corticosteroids.","A Phase 2, Open-label, Single-arm Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary Immune Thrombocytopenia Who Had an Insufficient Response to or Relapsed After First-line Corticosteroid Treatment (VAYHIT-P).","VAYHIT-P","Inclusion Criteria:\n\n* Signed informed consent and\u002For assent must be obtained from the participant and\u002For their parent(s)\u002Flegal guardian(s) before any study-related activity or assessment is performed. Informed consent must be obtained from participants once they reach the local legal age of adulthood during the study.\n* Male or female patients aged 5 to \\\u003C18 years on the day of signing informed assent\u002Fconsent (as appropriate for age).\n* A confirmed diagnosis of primary ITP, with insufficient response to, or relapse after a firstline corticosteroid therapy with or without IVIG.\n* Patients with platelet count \\\u003C30 G\u002FL for whom eltrombopag is clinically indicated (per physician's discretion) and with no contraindications to receive eltrombopag.\n* Patients who are up-to-date on childhood vaccinations as per the local recommended vaccination schedule.\n\nExclusion Criteria:\n\n* Patients with ITP who received previous second-line ITP treatments (other than corticosteroid therapy with or without IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (maximum one week) before or during screening are eligible.\n* Patients with key renal or hepatic laboratory abnormalities.\n* Patients with other hematologic diagnosis associated with cytopenias, including Evans Syndrome.\n* Patients with current or history of life-threatening bleeding due to thrombocytopenia.\n* Patients who are Human Immunodeficiency Virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) positive.\n* Patients with known active or uncontrolled infections requiring systemic treatment during the screening period or history of recurrent clinically significant infection.\n* Patients with hepatic impairment (Child-Pugh score \\>5, or equivalent).\n* Patients with concurrent bleeding disorders or coagulation disorders and\u002For receiving antiplatelet or anticoagulant medication.\n* Female patients who are nursing or pregnant.\n\nOther protocol-defined inclusion\u002Fexclusion may apply.","ALL","5 Years","17 Years",{"count":56,"type":57},36,"ESTIMATED","INTERVENTIONAL",[60],"PHASE2","The purpose of this study is to assess the efficacy, safety and pharmacokinetics (PK) of ianalumab (VAY736) in addition to eltrombopag treatment; and to inform the dose of ianalumab in pediatric patients (5 to \\\u003C18 years of age) with primary ITP who have had an insufficient response to or relapsed after first-line treatment with corticosteroids.",[63],"Primary Immune Thrombocytopenia (ITP)",[65,66,22,67,68,69,70],"Primary Immune Thrombocytopenia","ITP","ianalumab","first-line corticosteroid treatment","eltrombopag","Pediatric patients","NOT_YET_RECRUITING","2026-06-22",{"date":74,"type":75},"2026-06-25","ACTUAL",{"date":77,"type":57},"2027-02-08",{"date":79,"type":57},"2033-04-22",{"name":32,"class":6}]