CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Eltrombopagdrug
Likely dose
Eltrombopag 150mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01703169
NCT01703169Phase 2Completed

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

University of Utah·interventional·Posted Oct 10, 2012·Updated Oct 19, 2017

In Brief

A Phase 2 clinical trial evaluating Eltrombopag for Severe Aplastic Anemia and 2 related conditions. Completed, enrolled 13 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2012
Enrollment StartNov 1, 2012
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 13.7 years ago

Interventions

Eltrombopagdrug

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