CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 92 enrolled
Drug / intervention
Eltrombopag +1 moredrug
Likely dose
Not stated in 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/NCT01520909
NCT01520909Phase 3Completed

A Two Part, Double-blind, Randomized, Placebo-controlled and Open-label Study to Investigate the Efficacy, Safety and Tolerability of Eltrombopag, a Thrombopoietin Receptor Agonist, in Pediatric Patients With Previously Treated Chronic Immune (Idiopathic) Thrombocytopenic Purpura (ITP). PETIT2: Eltrombopag in PEdiatric Patients With Thrombocytopenia From ITP

GlaxoSmithKline·interventional·Posted Jan 30, 2012·Updated Mar 10, 2015

In Brief

A Phase 3 clinical trial evaluating Eltrombopag and Placebo for Idiopathic Thrombocytopenic Purpura. Completed, enrolled 92 participants across 51 sites in 13 countries.

Detailed Summary

The purpose of this study is to investigate the efficacy, safety and tolerability of eltrombopag in children with previously treated chronic immune thrombocytopenia who are between 1 and 17 years of age. This is a 2 part study. In part 1, patients will be randomized to receive either eltrombopag or placebo for 13 weeks. All patients who complete part 1 will enter part 2. In part 2, all patients will receive 24 weeks of eltrombopag.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Czechia, Germany, Hong Kong, Israel, Italy, Poland, Russia, Spain, Taiwan, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 30, 2012
Enrollment StartMar 1, 2012
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.4 years ago

Interventions

Eltrombopagdrug

Thrombopoietin receptor agonist

Placebodrug

Placebo with no active pharmaceutical ingredient