CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 20 enrolled
Drug / intervention
Eltrombopag +2 moredrug
Likely dose
Eltrombopag 75 mgfrom 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/NCT00902018
NCT00902018Phase 2Completed

The Effect of Eltrombopag on Platelet Survival: the Role of the B-cell L Extra Large (BcL-xL) Pathway

Weill Medical College of Cornell University·interventional·Posted May 14, 2009·Updated Mar 18, 2019

In Brief

A Phase 2 clinical trial evaluating Eltrombopag, Romiplostim, and 1 other intervention for Immune Thrombocytopenia. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The purpose of this study is to further evaluate the effects that eltrombopag (and romiplostim) have on platelets in subjects with chronic ITP. Eltrombopag is approved by the Food and Drug Administration (FDA) for the treatment of low platelets in patients with chronic ITP. It is being further studied by GlaxoSmithKline (now Novartis) in other conditions associated with low platelets. This research study is being done because eltrombopag has been shown to increase platelet counts in a different way than other therapies for ITP. The investigators want to further study how eltrombopag and romiplostim affect subjects and their platelets to determine how the study drug should best be used in ITP treatment.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 14, 2009
Enrollment StartJan 1, 2009
Primary CompletionSep 7, 2015
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 17.1 years ago

Interventions

Eltrombopagdrug

The 10 subjects will be treated with eltrombopag 75 mg once daily. Patients will be monitored 3 times, weekly, for the first 2 weeks, and then monitored as clinically indicated as they continue eltrombopag dosing for 3-4 months.

Romiplostimdrug

three of the patients treated with eltrombopag will be treated with weekly romiplostim at a dose of 10 micrograms/kg weekly for 2 weeks with testing at weekly intervals for 3 times

healthy controlsother

single blood draw for all measures included in the intervention arms