At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 203 enrolled
Drug / intervention
Romiplostimdrug
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.
A Single Arm, Open-label, Long-term Efficacy and Safety Study of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP)
In Brief
A Phase 3 clinical trial evaluating Romiplostim for Immune Thrombocytopenia. Completed, enrolled 203 participants across 78 sites in 17 countries.
Detailed Summary
This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric participants with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10\^9/L in the absence of ITP rescue medications for the past 4 weeks.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImmune Thrombocytopenia
CountriesAustralia, Belgium, Brazil, Canada, Czechia, France, Hungary, Israel, Mexico, Poland, Russia, South Africa, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartDec 2014
Primary CompletionAug 2018
Study CompletionAug 2019
TodayJul 2026
First PostedOct 30, 2014
Enrollment StartDec 10, 2014
Primary CompletionAug 30, 2018
Study CompletionAug 8, 2019
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 11.7 years ago
Interventions
Romiplostimdrug
Romiplostim subcutaneous weekly injection