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Romiplostim N01 for Injection for Secondary Prophylaxis of CIT in Breast Cancer
Plain-language guide to NCT07771881: phase 2 interventional trial of Romiplostim, 53 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07771881
- Phase
- phase 2
- Status
- not yet recruiting
- Start
- 2026-08
- Completion (planned or actual)
- 2028-04
- Participants
- 53 (estimated)
- Design
- na, open label (everyone knows who gets what), supportive_care
- Conditions studied
- Thrombocytopenia Chemotherapy Induced
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Romiplostim.
It had 1 arm (groups): Romiplostim N01 for Injection (experimental).
Romiplostim N01 for Injection.
The registry classes the interventions as drug.
Who Took Part
The registry lists 53 planned participants were the target.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Signed informed consent form. Age 18 to 75 years, either sex. Histologically or pathologically confirmed breast cancer. Platelet count \>100×10⁹/L at screening. No prior exposure to romiplostim/romiplostim N01.
The full record lists 9 inclusion and 14 exclusion criteria; among the exclusions: concomitant hematologic disorders;; prior radiation therapy to long bones or flat bones, or currently receiving/planned to receive radiation therapy (local radiation to the breast is permitted);; serious cardiac clinical symptoms or diseases within 6 months prior to screening;.
How the Study Was Run
Design: single-group and open-label.
Everyone knew when Romiplostim was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2026-08 with completion listed for 2028-04.
It ran at 1 site in China.
Its stated primary purpose is supportive care.
What Was Measured
The main thing measured (primary outcome): Proportion of patients achieving response (time frame: up to the completion of two consecutive treatment cycles, an average of 6 weeks).
It also tracked 4 secondary outcomes, for example Proportion of patients with platelet count <50×10⁹/L per cycle, Minimum and maximum platelet counts, Number of symptomatic bleeding episodes during the treatment period and Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
What This Means in Plain Language
Put simply, this is a phase 2 trial of Romiplostim in 53 people.
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, 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.