Safety and Efficacy of Eltrombopag at Escalated Doses

PHASE2CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

February 15, 2017

Study Completion Date

October 16, 2017

Conditions
Immune ThrombocytopeniaPlatelet Disorder
Interventions
DRUG

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.

DRUG

Placebo

Trial Locations (1)

10065

Weill Cornell Medicine, New York

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Weill Medical College of Cornell University

OTHER