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An Observational Study to Evaluate the Efficacy of Biweekly Romiplostim in Adult Patients With ITP
Plain-language guide to NCT02338414: phase 2 interventional trial of Romiplostim, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02338414
- Phase
- phase 2
- Status
- status unknown
- Start
- 2015-01
- Completion (planned or actual)
- 2015-12
- Participants
- 20 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Immune Thrombocytopenia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 2 trial tested Romiplostim.
It had 1 arm (groups): Romiplostim (other).
Patients receiving romiplostim due to ITP.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 20 planned participants were the target.
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: Subject has an ability to provide written informed consent prior to participating to the study. Subject is male or female ≥ 18 years of age. Subject has a diagnosis of immune thrombocytopenia (ITP) per the American Society of Hematology guidelines. If subject had ever received TPO receptor agonist before, the patient can participate this study only after 8 weeks' wash out period.
The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: subject has a history of hematological malignancy, myeloproliferative disorder, myelodysplastic syndrome (mds), or bone marrow stem cell disorder; subject has participated in any study evaluating peg-rhumgdf, recombinant human thrombopoietin (rhutpo), or related platelet product within 8 weeks; subject has a known hypersensitivity to any recombinant e coli-derived product.
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 2015-01 with completion listed for 2015-12.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Romiplostim in 20 people.
Its size is small, so on its own it can only give an early look.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
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.