A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
A legfontosabb adatok
- Hol
- Aurora, Billings, Boston, Evanston, Farmington Hills, Nyack, The Bronx, Worcester és Yuma (Egyesült Államok)Mind a 9 helyszín megnézése
- Fázis
- 3. fázis
Helyszínek itt: Egyesült Államok
- University of Colorado AnschutzAurora, Egyesült ÁllamokNo longer taking part
- St. Vincent Frontier Cancer CenterBillings, Egyesült ÁllamokNo longer taking part
- Boston Medical CenterBoston, Egyesült ÁllamokNo longer taking part
- Endeavor HealthEvanston, Egyesült ÁllamokNo longer taking part
- Michigan Center of Medical ResearchFarmington Hills, Egyesült ÁllamokNo longer taking part
- Hematology Oncology Association of RocklandNyack, Egyesült ÁllamokNo longer taking part
- Montefiore Medical CenterThe Bronx, Egyesült ÁllamokNo longer taking part
- Umass Memorial Medical CenterWorcester, Egyesült ÁllamokNo longer taking part
- Yuma Regional Medical CenterYuma, Egyesült ÁllamokNo longer taking part
A vizsgálat adatai
- Ki végzi
- Novartis Pharmaceuticals
- Azonosító
- NCT05653219EU 2024-512890-28-00
- A regiszteradat frissítve
- 2026. november 9.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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)
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.
Bevonási feltételek: 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.
Kizáró feltételek: 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 concurrent coagulation disorders and/or receiving antiplatelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid (≤150 mg daily); 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; Nursing (breast feeding) or pregnant women; Other protocol-defined inclusion/exclusion criteria may apply.