Research and Clinical Trials

Title  
A three part, staggered cohort, open-label and double blind, randomized, placebo controlled study to investigate the efficacy, safety, tolerability and pharmacokinetics of eltrombopag, a thrombopoietin receptor agonist, in previously treated pediatric
Brief Description  
This study is a Phase II, multi-center, 3 part, staggered cohort, open-label and double blind, randomized, placebo controlled study involving 3 age-determined cohorts. Daily dosing with eltrombopag will begin with 5 subjects in an oldest age cohort in an open label fashion, and a review of safety, pharmacokinetic and platelet count data will be performed regularly. If no safety concerns are identified after 12 weeks, 18 additional subjects will be randomised to eltrombopag or placebo (2:1 random
Who may be Eligible  
Subjects who are refractory or have relapsed after at least one prior ITP therapy or are not eligible, for a medical reason, for other treatments. Age 1 - < 6 years at study entry. Currently enrolling only to the 12-17 year-old cohort. Anticipate opening cohort for youngest cohort upon central review of data.
Speciality/Disorder  
Pediatric Hematology
IRB Number  
12-09-04A
Principal Investigator  
Kaplan, Joel

For More Information, Contact  Beatriz  , Perez-Li
Phone:  (704) 446-5285  Fax:  (704) 355-1188  
Email:  beatriz.perezli@carolinashealthcare.org
Address:1025 Morehead Medical Drive Suite 600 Charlotte, NC 28204
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