Ropustin for Refractory Aplastic Anaemia After Radiotherapy - a Single-centre, Prospective, Open-label, Single-arm Study

What Was Tested

This registered phase 4 trial tested Romiplostim for anemia.

It had 1 arm (groups): Romiplostim group (experimental).

The registry classes the interventions as drug.

Who Took Part

40 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, male or female. Baseline liver and renal function is less than two times the normal value. No active infection. Agreed to sign the consent form. Eastern Cooperative Oncology Group (ECOG) score of 0-2.

The full record lists 7 inclusion and 12 exclusion criteria; among the exclusions: other causes of whole blood cytopenia, such as myelodysplastic syndromes (mds); presence of cytogenetic evidence of clonal haematological bone marrow disorders (mds, aml); hematopoietic stem cell transplantation (hsct) prior to enrolment.

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 2024-07-30 with completion listed for 2025-07-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: ORR (time frame: 3 months, 6 months). CRR (time frame: 3 months, 6months).

It also tracked 1 secondary outcome, for example safety events.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Romiplostim in 40 people with anemia.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, Anemia research.