CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 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/NCT01891994
NCT01891994Phase 2Completed

Extended Dosing With Eltrombopag in Refractory Severe Aplastic Anemia

National Heart, Lung, and Blood Institute (NHLBI)·interventional·Posted Jul 3, 2013·Updated Apr 25, 2023

In Brief

A Phase 2 clinical trial evaluating Eltrombopag for Severe Aplastic Anemia (SAA). Completed, enrolled 40 participants across 1 site.

Detailed Summary

Background: \- Eltrombopag is a drug being tested for treating severe aplastic anemia. It can help improve blood counts in these patients. However, researchers do not know how long the drug can and should be taken for this type of anemia. Objectives: \- To look at whether 6 months of treatment with eltrombopag can improve patient s blood counts. Eligibility: \- Individuals at least 2 years of age who are taking eltrombopag for severe aplastic anemia. Design: * Participants will take eltrombopag by mouth once a day for 6 months. * Blood samples will be collected every 2 weeks for the first 6 months. Bone marrow samples will be collected at 3 and 6 months. These samples will look at the effects of the study drug on the marrow. * Participants will continue to take the study drug for as long as it is effective and if the side effects are not severe.

Study Details

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

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 3, 2013
Enrollment StartJun 28, 2013
Primary CompletionOct 16, 2017
Study CompletionAug 24, 2022
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 13.0 years ago

Interventions

Eltrombopagdrug

Oral administration of eltrombopag 150mg/day (75 mg/day for East Asian ancestry) for 6 months