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Amgen Megakaryopoiesis Protein 2 (AMG 531) in Thrombocytopenic Subjects With Immune Thrombocytopenic Purpura (ITP)
Plain-language guide to NCT00117143: phase 1, phase 2 interventional trial of Romiplostim, 16 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00117143
- Phase
- phase 1, phase 2
- Status
- completed
- Start
- 2002-12-02
- Completion (planned or actual)
- 2004-07-19
- Participants
- 16 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Thrombocytopenic Purpura
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 1, phase 2 trial, researchers set out to test Romiplostim.
The purpose of this study is to assess the safety and tolerability of AMG 531 (romiplostim), a novel thrombopoiesis-stimulating peptibody, and its effect on platelet counts in adults with immune thrombocytopenic purpura.
It had 1 arm (groups): Romiplostim (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 16 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Greater than or equal to 3 months history of ITP, regardless of splenectomy status, and completion of at least 1 prior treatment for ITP. Ability to give informed consent.
The full record lists 3 inclusion and 1 exclusion criteria; among the exclusions: known history of arterial thrombosis, active malignancy, or bone marrow stem cell disorder.
How the Study Was Run
Design: sequential and open-label.
Nothing was hidden in this open-label Romiplostim study: the participants and staff both knew the treatment.
It started in 2002-12-02 with completion listed for 2004-07-19.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Number of Participants With Adverse Events. Number of Participants With Positive Anti-Romiplostim Antibodies (time frame: Days 29 and 78).
It also tracked 7 secondary outcomes, for example Number of Participants Who Achieved a Targeted Therapeutic Platelet Response, Number of Participants With Peak Platelet Counts of ≥ 100 x 10⁹ Cells/L, Number of Participants With Peak Platelet Counts of ≥ 450 x 10⁹ Cells/L, Change From Baseline to Peak Platelet Level, Time to Peak Platelet Count and Duration Within the Targeted Therapeutic Range.
What This Means in Plain Language
Put simply, this is a phase 1, phase 2 trial of Romiplostim in 16 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Romiplostim compound page, all human trials.
Our Notes on the Compound
Romiplostim: A peptide-antibody fusion (peptibody) that activates the thrombopoietin receptor to raise platelet counts; sold as Nplate.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.