Efficacy and Safety of Romiplostim N01 for Injection in Promoting Platelet Reconstitution After Allogeneic Hematopoietic Stem Cell Transplantation

What Was Tested

In this phase 2 trial, researchers set out to test Romiplostim.

This is a prospective, single-center, randomized controlled, investigator-initiated clinical study.

It had two arms (groups): Romiplostim N01 (experimental) and Control Group (no intervention).

Participants in the control group receive identical standard allo-HSCT supportive care, with the exception of Romiplostim N01 for Injection.

The registry classes the interventions as drug.

Who Took Part

87 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: 1.Subjects must understand study procedures, be willing to comply with the study protocol, and provide written informed consent prior to any study-related procedures. AST, ALT and alkaline phosphatase \< 3 × upper limit of normal (ULN);.

The full record lists 6 inclusion and 2 exclusion criteria; among the exclusions: 1\. subjects who have received romiplostim, eltrombopag, or other tpo-ra thrombopoietic agents within 1 month prior to enrollment; participation in any other interventional clinical study of investigational drugs or devices within 1 month prior to screening.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Romiplostim group and the comparison group should start out alike.

The Romiplostim group and the comparison group ran side by side rather than switching.

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.

It started in 2026-11-01 with completion listed for 2028-06-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Platelet engraftment time (time frame: From Day +1 after allogeneic-HSCT up to 1 year post-transplant).

It also tracked 10 secondary outcomes, for example Neutrophil engraftment time, Median time to achieve complete remission (CR), Incidence of primary poor graft function (PGF), Incidence of secondary platelet recovery failure, Incidence of graft-versus-host disease and Incidence of primary graft failure.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Romiplostim in 87 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.