drugset / Trial / NCT01703169

Efficacy and Safety of Eltrombopag In Patients With Severe and Very Severe Aplastic Anemia

NCT01703169

Phase 2 Completed 13 enrolled University of Utah Novartis · collab
NaSingle-groupOpen-labelTreatment

Summary

The investigators hypothesis is that eltrombopag given to patients with moderate to very severe aplastic anemia will result in an increase in platelet counts. The investigators hypothesize that in patients with moderate to very severe aplastic anemia, treatment with eltrombopag will lead to fewer platelet transfusions, red blood cell transfusions, and fewer bleeding events. The investigators hypothesize that in patients with moderate to very severe aplastic anemia, eltrombopag will have an acceptable toxicity rate \<3%, at doses that result in increased platelet counts. Finally the investigators hypothesize that plasma eltrombopag levels in peripheral blood will correlate with improved platelet counts.

Timeline

Start
2012-11
Primary completion
2016-06
Completion
2016-06

Drugs

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

Indications