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NCT05653219
A Study of Efficacy and Safety of Ianalumab Versus Placebo in Addition to Eltrombopag in Primary Immune Thrombocytopenia Patients Who Failed Steroids
Conditions: Primary Immune Thrombocytopenia
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 152
Sponsor: Novartis Pharmaceuticals
Location: Yuma Regional Medical Center Yuma Arizona
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.
Eligibility Criteria
Key Inclusion criteria
1. Male or female patients aged 18 years and older on the day of signing the informed consent.
2. A signed informed consent must be obtained prior to participation in the study.
3. A diagnosis of primary ITP, with insufficient response to, or relapse after a first-line corticosteroid therapy ± IVIG.
4. Patient with platelet count \
Source: ClinicalTrials.gov (NCT05653219). StuddyBuddy aggregates publicly available trial information.
