CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 9 enrolled
Drug / intervention
Eltrombopag Tablets +1 moredrug
Likely dose
Eltrombopag Tablets 12.5 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/NCT02201290
NCT02201290Phase 3Completed
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An Extension Study of Eltrombopag in Pediatric Patients With Chronic Immune (Idiopathic) Thrombocytopenia Purpura (ITP)

Novartis Pharmaceuticals·interventional·Posted Jul 28, 2014·Updated Jul 5, 2019

In Brief

A Phase 3 clinical trial evaluating Eltrombopag Tablets and Eltrombopag PfOS for Purpura, Thrombocytopenic, Idiopathic. Completed, enrolled 9 participants across 3 sites.

Detailed Summary

This was an open-label Phase III extension study to evaluate the long-term safety of eltrombopag in pediatric patients with chronic ITP who previously participated in study TRA115450. This study allowed dosing of eltrombopag at an individualized dose for each subject based upon platelet count. The starting dose was based on the subject's dose at the end of the TRA115450 study. The maximum dose was 75 mg daily.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPurpura, Thrombocytopenic, Idiopathic
CountriesRussia
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 28, 2014
Enrollment StartJun 18, 2013
Primary CompletionJul 4, 2017
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 11.9 years ago

Interventions

Eltrombopag Tabletsdrug

Eltrombopag tablets will be white, round film coated tablets containing eltrombopag olamine equivalent to 12.5 mg, 25 mg, 50 mg and 75 mg of eltrombopag. The 12.5 mg tablet will be smaller than the 25 mg, 50 mg and 75 mg tablets. Subjects will receive maximum dose of 75 mg once daily (QD).

Eltrombopag PfOSdrug

Eltrombopag PfOS is a reddish-brown to yellow powder contained inside an elongated sachet. Each sachet will contain eltrombopag olamine equivalent to 20 mg of eltrombopag per gram of powder. Subjects will receive maximum dose of 75 mg once daily (QD)