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NCT07660172

PHASE2

A Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary ITP Who Failed Corticosteroids.

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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 \<18 years of age) with primary ITP who have had an insufficient response to or relapsed after first-line treatment with corticosteroids.

Official title: 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).

Key Details

Gender

All

Age Range

5 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2027-02-08

Completion Date

2033-04-22

Last Updated

2026-06-25

Healthy Volunteers

Conditions

Primary Immune Thrombocytopenia (ITP)

Interventions

BIOLOGICAL

Ianalumab

Liquid in a vial Concentrate for solution for infusion

DRUG

Eltrombopag

Film-coated tablet and also Powder for oral suspension

Inclusion Criteria: * Signed informed consent and/or assent must be obtained from the participant and/or their parent(s)/legal 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. * Male or female patients aged 5 to \<18 years on the day of signing informed assent/consent (as appropriate for age). * A confirmed diagnosis of primary ITP, with insufficient response to, or relapse after a firstline corticosteroid therapy with or without IVIG. * Patients with platelet count \<30 G/L for whom eltrombopag is clinically indicated (per physician's discretion) and with no contraindications to receive eltrombopag. * Patients who are up-to-date on childhood vaccinations as per the local recommended vaccination schedule. Exclusion Criteria: * 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. * Patients with key renal or hepatic laboratory abnormalities. * Patients with other hematologic diagnosis associated with cytopenias, including Evans Syndrome. * Patients with current or history of life-threatening bleeding due to thrombocytopenia. * Patients who are Human Immunodeficiency Virus (HIV), hepatitis C virus (HCV), hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) positive. * Patients with known active or uncontrolled infections requiring systemic treatment during the screening period or history of recurrent clinically significant infection. * Patients with hepatic impairment (Child-Pugh score \>5, or equivalent). * Patients with concurrent bleeding disorders or coagulation disorders and/or receiving antiplatelet or anticoagulant medication. * Female patients who are nursing or pregnant. Other protocol-defined inclusion/exclusion may apply.