Trials / Completed
CompletedNCT02279173
Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)
A Single Arm, Open-label, Long-term Efficacy and Safety Study of Romiplostim in Thrombocytopenic Pediatric Subjects With Immune Thrombocytopenia (ITP)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 203 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 1 Year – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Romiplostim | Romiplostim subcutaneous weekly injection |
Timeline
- Start date
- 2014-12-10
- Primary completion
- 2018-08-30
- Completion
- 2019-08-08
- First posted
- 2014-10-30
- Last updated
- 2022-06-23
- Results posted
- 2019-08-28
Locations
78 sites across 17 countries: United States, Australia, Belgium, Brazil, Canada, Czechia, France, Hungary, Israel, Mexico, Poland, Russia, South Africa, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Source: ClinicalTrials.gov record NCT02279173. Inclusion in this directory is not an endorsement.