NCT00903929

Phase I Study of Eltrombopag for Promoting Thrombopoiesis After Total Body Irradiation

Phase I Study of Eltrombopag for Promoting Thrombopoiesis in Patients Undergoing Stem Cell Transplantation After Total Body Irradiation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Jane Liesveld · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients who undergo total body irradiation (TBI) for stem cell transplantation have prolonged periods of low counts of specific blood cells called platelets. These low platelets counts can cause bleeding and infection. Thus far, no drug is available for use to speed the recovery of platelets, and therefore transfusions are often necessary. The purpose of this study is to test the safety of a drug called eltrombopag in patients who have received TBI. The investigators want to find out what effects, good or bad, it has on people with low platelet counts due to treatment with TBI. The investigators will also be testing how well eltrombopag may work at different doses and determine if this drug speeds up the recovery of the platelets.

Conditions

• Thrombocytopenia
• Acute Radiation Syndrome

Interventions

Type	Name	Description
DRUG	Eltrombopag	dose escalation

Timeline

• Start date: 2009-12-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2009-05-19
• Last updated: 2016-05-05
• Results posted: 2016-05-05