"End of EXTEND: Observing for Cure in Patients With Chronic ITP"
Recruitment status was: Recruiting
This study proposes to observe whether a stable platelet count would be maintained without additional treatment in the long term in at least a proportion of patients who have discontinued eltrombopag taken for at least 4 months. This requires that if patients stop treatment with eltrombopag, they are not immediately transitioned to further treatment unless it is necessary.
The objective of the study is to assess how frequently patients who have discontinued eltrombopag attain a stable, treatment-free, unmaintained adequate platelet count 4 to 8 weeks after discontinuing eltrombopag and how long such a response lasts (if it occurs).
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||"End of EXTEND: Observing for Cure in Patients With Chronic ITP"|
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||August 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
discontinuation of eltrombopag
ITP subjects who have discontinued the use of eltrombopag
Other: Observational study
Observation of subjects as they discontinue the use of eltrombopag
Other Name: eltrombopag, promacta
Please refer to this study by its ClinicalTrials.gov identifier: NCT01386723
|United States, New York|
|Weill Cornell Medical College/New York Presbyterian Hospital|
|NY, New York, United States, 10065|
|Principal Investigator:||James B. Bussel, M.D.||Weill Medical College of Cornell University|