Clinical Trial: End of EXTEND: Discontinuation of Medication for Patients With Immune Thrombocytopenia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: End of EXTEND: Observing for Sustained Response Despite Discontinuation of Medication in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP) Treated With El

Brief Summary:

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).


Detailed Summary:
Sponsor: Weill Medical College of Cornell University

Current Primary Outcome: Platelet Response [ Time Frame: 6 months ]

To determine the frequency of a sustained response of at least 6 months in subjects with persistent or chronic ITP who have been receiving eltrombopag for a minimum of four months and are able to discontinue it within two years of initiating the tapering


Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Weill Medical College of Cornell University

Dates:
Date Received: June 13, 2011
Date Started: June 2011
Date Completion: June 30, 2019
Last Updated: January 31, 2017
Last Verified: January 2017