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The purpose of this study is to investigate the safety and effectiveness of eltrombopag in treating children and adolescents with newly diagnosed immune thrombocytopenia (ITP). Patients aged between 1 to <18 years with newly diagnosed ITP will be eligible to enroll if they consent to participate within ten days from diagnosis and have not received any prior therapy or if they have failed standard management and are within the first three months from diagnosis. If you choose to participate, you will be on study for about 1 year. You will be randomly assigned to receive the study drug eltrombopag or standard therapy. Participation in this study includes weekly procedures such as assessments, physical exams, review of medical records, blood draws and questionnaires for 12 weeks and then about monthly or less often for up to 1 year.

Who Do I Contact?

If you are interested in participating in the study or want to learn more please contact our study team at kondep [at] chop.edu or 267-426-7634.

Eligibility & Criteria

IRB #:
18-015560
Official Title:
A Phase 3 Study of Eltrombopag Vs. Standard First-Line Management for Newly Diagnosed Immune Thrombocytopenia (ITP) In Children
Study Phase:
Phase III
Eligible Age Range:
1 Year - 17.5 Years
Gender:
All
Study Categories:

Visit Criteria

There will be up to 16 study visits over a 1 year period. In addition, we will follow you for 30 days after your last dose for this study to see how you are doing. The total number of study visits depends on the treatment group you are randomized to. You will be paid $30/visit for completing certain onsite study visits.