Standard Immunosuppressive Therapy Combined With Romiplostim N01 as First-line Treatment for Severe Aplastic Anemia

Plain-language guide to NCT06613880: phase 2 interventional trial of Romiplostim, anemia, 48 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT06613880
Phase: phase 2
Status: status unknown
Start: 2024-10-24
Completion (planned or actual): 2026-01-31
Participants: 48 (estimated)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Aplastic Anemia; TPO Receptor Agonists
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 2 trial tested Romiplostim for anemia.

It will include 48 patients with newly diagnosed SAA.

It had 1 arm (groups): p-ALG+Romiplostim N01+CsA (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 48 planned participants were the target.

It was open to people of any sex aged from 12 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age ≥ 12 years. Diagnosis of severe or very severe aplastic anemia. Patients are unconditionally or unacceptable undergoing allogeneic hematopoietic stem cell transplantation. ECOG performance status ≤2. Willing and able to comply with the requirements for this study and written informed consent.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: received \> 4 weeks of tpo-ra drug before treatment; received \> 4 weeks of immunosuppressive therapy before treatment; history of thromboembolic disease.

How the Study Was Run

Design: single-group and open-label.

Nothing was hidden in this open-label Romiplostim study: the anemia 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 2024-10-24 with completion listed for 2026-01-31.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Overall response rate (time frame: Within 27 weeks post treatment).

It also tracked 3 secondary outcomes, for example Overall response rate, Time to hematological response and Incidence of adverse events.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Romiplostim in 48 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.

Our Notes on the Compound

Romiplostim: A peptide-antibody fusion (peptibody) that activates the thrombopoietin receptor to raise platelet counts; sold as Nplate.

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.