At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 66 enrolled
Drug / intervention
Romiplostimbiological
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.
An Open Label Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune (Idiopathic) Thrombocytopenia Purpura (ITP)
In Brief
A Phase 3 clinical trial evaluating Romiplostim for Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP. Completed, enrolled 66 participants across 31 sites in 4 countries.
Detailed Summary
This is an extension study designed to assess the safety and durability of platelet count increases with romiplostim treatment of thrombocytopenic patients with immune (Idiopathic) thrombocytopenia purpura. This study is available to pediatric patients who have completed a previous romiplostim ITP study and meet the eligibility criteria of this study.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP
CountriesAustralia, Canada, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
First PostedFeb 2010
Primary CompletionJan 2017
TodayJul 2026
First PostedFeb 19, 2010
Enrollment StartDec 30, 2009
Primary CompletionJan 12, 2017
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 16.4 years ago
Interventions
Romiplostimbiological
Administered by subcutaneous injection once a week.