drugset / Trial / NCT00903929

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

NCT00903929

Phase 1 Completed 19 enrolled Jane Liesveld
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2009-12
Primary completion
2015-12
Completion
2015-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Eltrombopag Small molecule 75 mg Oral
Subject Eltrombopag Small molecule 150 mg Oral
Subject Eltrombopag Small molecule 225 mg Oral
Subject Eltrombopag Small molecule 300 mg Oral