At a glance
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A Phase III Study of Eltrombopag vs Standard Front Line Management for Newly Diagnosed Immune Thrombocytopenia in Children
In Brief
A Phase 3 clinical trial evaluating Eltrombopag, Steroids, and 2 other interventions for Immune Thrombocytopenia. Completed, enrolled 122 participants across 27 sites.
Detailed Summary
This is an investigator initiated, multicenter, open label, randomized phase 3 study for subjects with newly diagnosed ITP from ages 1 to less than 18 years old.
Study Details
Timeline
Interventions
Starting dose for eltrombopag will be based on manufacturer recommendations, and drug will be titrated to effect per guidelines. * Children 1 to 5 years: Initial: 25 mg once daily * Children ≥6 years and Adolescents: Initial: 50 mg once daily (25 mg once daily for patients of East-Asian ethnicity \[e.g., Chinese, Japanese, Korean, Taiwanese\]) Dose should be titrated based on platelet response. Maximum dose: 75 mg once daily.
Prednisone/Prednisolone 4mg/kg/day (Max 120 mg/day) x 4 day
IVIG 1 g/kg x1 (no steroids for pre-medication or adjunctive therapy)
Anti-D globulin 75 mcg/kg x1 (no steroids for pre-medication or adjunctive therapy)