Trials / Completed
CompletedNCT00515203
Safety and Efficacy Study of Romiplostim (AMG 531) to Treat ITP in Pediatric Subjects
A Randomized, Double-Blind, Placebo-controlled Phase 1/2 Study to Determine the Safety and Efficacy of Romiplostim (AMG 531) in Thrombocytopenic Pediatric Subjects With Chronic Immune (Idiopathic) Thrombocytopenic Purpura
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 1 Year – 17 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and tolerability of romiplostim (AMG 531) in the treatment of thrombocytopenia in pediatric subjects with chronic ITP. We will also evaluate the efficacy of romiplostim (AMG 531) and characterize the pharmacokinetics of romiplostim (AMG 531). It is anticipated that romiplostim (AMG 531), when given at an effective dose and schedule, will be well tolerated treatment for thrombocytopenia among pediatric subjects with chronic ITP.
Conditions
- Idiopathic Thrombocytopenic Purpura
- Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
- Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts. |
| DRUG | AMG 531 | Starting dose of 1.0 ug/kg. Dose adjustments are made throughout the study based on individual platelet counts. |
Timeline
- Start date
- 2007-07-01
- Primary completion
- 2009-03-01
- Completion
- 2009-08-01
- First posted
- 2007-08-13
- Last updated
- 2014-07-25
- Results posted
- 2011-03-01
Source: ClinicalTrials.gov record NCT00515203. Inclusion in this directory is not an endorsement.