← Human Trials & Peer-Reviewed Studies
A Study Evaluating the Safety and Efficacy of Long-term Dosing of Romiplostim in Thrombocytopenic Pediatric Patients With Immune (Idiopathic) Thrombocytopenia Purpura
Plain-language guide to NCT01071954: phase 3 interventional trial of Romiplostim, 66 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01071954
- Phase
- phase 3
- Status
- completed
- Start
- 2009-12-30
- Completion (planned or actual)
- 2017-01-12
- Participants
- 66 (actual)
- Design
- na, open label (everyone knows who gets what), supportive_care
- Conditions studied
- Thrombocytopenia in Pediatric Subjects With Immune Idiopathic Thrombocytopenic Purpura ITP
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Romiplostim.
This study is available to pediatric patients who have completed a previous romiplostim ITP study and meet the eligibility criteria of this study.
It had 1 arm (groups): Romiplostim (experimental).
The registry classes the interventions as biological.
Who Took Part
Enrollment: 66 actual participants took part.
It was open to people of any sex aged from 1 Year with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Subject or subject's legally acceptable representative has provided informed consent. Subject completed a romiplostim study for the treatment of thrombocytopenia in pediatric subjects with ITP.
The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: subject has any new active malignancy diagnosed since enrollment in the previous romiplostim itp study; subject received any alkylating agents within four weeks before the screening visit or anticipated use during the time of the proposed study; other investigational medications are excluded.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Romiplostim study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2009-12-30 with completion listed for 2017-01-12.
It ran at 31 sites in United States (24), Australia (3), Canada (3) and Spain (1).
Its stated primary purpose is supportive care.
What Was Measured
Researchers chose this as the main measure: Number of Participants With Adverse Events. Duration Adjusted Rate of Treatment Emergent Adverse Events. Number of Participants Who Developed Antibodies to Romiplostim.
It also tracked 2 secondary outcomes, for example Percentage of Participants With a Platelet Response and Percentage of Participants Who Used Concomitant ITP Therapy.
What This Means in Plain Language
Put simply, this is a phase 3 trial of Romiplostim in 66 people.
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.