35
Participants
Start Date
February 28, 2013
Primary Completion Date
February 15, 2017
Study Completion Date
October 16, 2017
Eltrombopag
Eltrombopag will be administered for 8 weeks or until the platelet count exceeds 150,000; at this point dosing will stop, subject will be considered a responder and the subject will eligible for entering Part 2 (the long term treatment part of the study. The dose at which the subject achieved the primary endpoint (\> 50,000 and increase by \> 20,000) will be considered the dose of response. Dose escalation will continue, despite satisfaction of the primary endpoint of study (\> 50,000 and \> 20,000 above baseline), unless the platelet count reaches the lower limit of normal range 150,000. Subjects will stop study medication if the platelet count is within the normal range, thereby minimizing any safety risk associated with elevated platelet count.
Placebo
Weill Cornell Medicine, New York
Collaborators (1)
Novartis
INDUSTRY
Weill Medical College of Cornell University
OTHER