NCT01703169

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Aplastic Anemia
• Very Severe Aplastic Anemia
• Moderate Aplastic Anemia

Interventions

Type	Name	Description
DRUG	Eltrombopag	Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count

Timeline

• Start date: 2012-11-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2012-10-10
• Last updated: 2017-10-19
• Results posted: 2017-10-19

Locations

1 site across 1 country: United States