A Phase 3 Randomized, Double-blind Study of Ianalumab (VAY736) Versus Placebo in Addition to Eltrombopag in Patients With Primary Immune Thrombocytopenia (ITP) Who Had an Insufficient Response or Relapsed After First Line Steroid Treatment (VAYHIT2)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05653219Tipo: INTERVENTIONALInicio: 2 de feb de 2023Fin estimado: 8 de abr de 2028

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to evaluate the effect of two different doses of ianalumab added to eltrombopag to prolong Time to Treatment Failure (TTF) in adults with primary ITP who failed previous first-line treatment with steroids.

Descripción detallada

This is a multicenter, randomized, double-blinded phase 3 study to assess efficacy and safety of two different doses of ianalumab versus placebo in addition to eltrombopag in adults with primary ITP (platelet count \<30 G/L) who failed previous first-line treatment with corticosteroids. After completion of the screening period, the participants will enter the randomized treatment period (ianalumab/placebo with eltrombopag) followed by the eltrombopag tapering period. Afterwards, all participants will enter the follow-up period to be monitored for efficacy and safety or safety only depending on how the participants responded to the study treatment.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 100 YearsSexo: ALL

Criterios de inclusión

Male or female patients aged 18 years and older on the day of signing the informed consent.
A signed informed consent must be obtained prior to participation in the study.
A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG.
Patient with platelet count \<30G/L (whom eltrombopag is clinically indicated as per physician's discretion) and with no contraindication to receive eltrombopag

Criterios de exclusión

ITP patients who received second-line ITP treatments (other than steroid therapy± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonists (TPO-RAs) for a limited time (max one week) before screening are eligible.
Patients with key lab abnormalities and patients with Evans syndrome or any other cytopenia, (patients with low grade anemia related to bleeding or iron deficiency are eligible).
Patients with history of clinically significant hematological disorders, or with marked altered hematologic parameters
Patients with current or history of life-threatening bleeding
Patient that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAb)-positive. HBcAb-positive patients can be enrolled if HBsAg negative, HBV DNA negative, no pre-existing liver fibrosis is present and antiviral prophylaxis is given
Patients with known active or uncontrolled infection requiring systemic treatment during screening period
Patients with hepatic impairment
Patients with concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid (≤150 mg daily)
Nursing (breast feeding) or pregnant women

Intervenciones

biological

Ianalumab

Concentrate for solution for infusion for intravenous use

drug

Eltrombopag

Film-coated tablet for oral use

drug

Placebo

Concentrate for solution for infusion for intravenous use.

Ubicaciones

Novartis Investigative Site

CABA, Argentina

Patrocinadores

PrincipalNovartis Pharmaceuticals

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