A phase 3, randomized, double- blind, study of ianalumab (VAY736) versus placebo in addition to eltrombopag in primary immune thrombocytopenia (ITP) patients who failed steroids.
- Conditions
- Primary immune thrombocytopenia (ITP)MedDRA version: 23.0Level: PTClassification code: 10083842Term: Immune thrombocytopenia Class: 100000004851Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Registration Number
- CTIS2024-512890-28-00
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 139
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., Patients with platelet count <30 G/L for whom eltrombopag is clinically indicated as per physician’s discretion and with no contraindication to receive eltrombopag.
ITP patients who received second-line ITP treatments (other than corticosteroid therapy ± IVIG) including splenectomy. However, patients exposed to thrombopoietin receptor agonist (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-treating bleeding., Patients that are Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B surface Antigen (HBsAg)/ Hepatitis B core antibody (HBcAb)- positive., Patients with known active or uncontrolled infection requiring systemic treatment during screening period., Patients with hepatic impairment with Child-Pugh score >5, Patients with concurrent coagulation disorder and/or receiving anti-platelet or anticoagulant medication with an exemption of low dose of acetylsalicylic acid (=150 mg daily)., Female patients who are pregnant or nursing.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method