NCT01386723

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 35 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Immune Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Discontinuation of eltrombopag	Observation of subjects as they discontinue the use of eltrombopag

Timeline

• Start date: 2011-06-01
• Primary completion: 2017-01-31
• First posted: 2011-07-01
• Last updated: 2018-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study