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Romiplostim N01 in Chemoradiotherapy-induced Aplastic Anemia
Plain-language guide to NCT07572084: phase 2 interventional trial of Romiplostim, anemia, 43 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07572084
- Phase
- phase 2
- Status
- not yet recruiting
- Start
- 2026-04
- Completion (planned or actual)
- 2028-12
- Participants
- 43 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Aplastic Anemia
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Romiplostim for anemia.
It had 1 arm (groups): Romiplostim N01 (experimental).
The registry classes the interventions as drug.
Who Took Part
43 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: Age ≥ 18 years old;. Diagnosed with relapsed/refractory chemoradiotherapy-induced AA. Relapsed/ refractory was defined as patients who had no response to at least 3 months of cyclosporine or thrombopoietin receptor agonists (TPO-RAs) such as eltrombopag;. With baseline liver and kidney functions \<2 upper limit of normal (ULN);. Without active infection that cannot be controlled by standard treatment;. Signed the informed consent;.
The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: had other primary or secondary bone marrow failure (bmf) diseases, such as fanconi anemia, congenital keratinization disorder, etc.;; with evidence of clonal hematological bone marrow diseases (mds, aml) in cytogenetics;; received hematopoietic stem cell transplantation before enrollment;.
How the Study Was Run
It was run as a single-group and open-label study.
Being open-label, the Romiplostim study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2026-04 with completion listed for 2028-12.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): ORR (Overall Response Rate) (time frame: 3-month, 6-month).
It also tracked 4 secondary outcomes, for example CRR, Adverse event (AE) rate, Predictive factors for ORR or CRR and Clonal evolution rate.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Romiplostim in 43 people with anemia.
Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Romiplostim compound page, Anemia research.
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.