A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary … (NCT05653219) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
United States152 participantsStarted 2023-02-02
Plain-language summary
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.
Who can participate
Age range18 Years – 100 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
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What they're measuring
1
Time from randomization until treatment failure
Timeframe: Randomization to until end of study (up to 39 months after randomization of last participant)
. 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)