A Study on the Treatment of CTIT of the Efficacy and Safety With Romiplostim N01 Compared to Recombinant Human Interleukin-11

What Was Tested

This registered phase 3 trial tested Romiplostim.

It had two arms (groups): Romiplostim N01 (experimental) and Recombinant Human Interleukin-11 (active comparator).

The registry classes the interventions as drug.

Who Took Part

88 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: 1\. Voluntarily participate in this study, sign an informed consent form, and strictly complied with the study protocol requirements；. 2.Age range from 18 to 75 years old，male or female；. 3.Diagnosed with a malignant tumor by histopathology and/or cytology and is receiving anti-tumor therapy such as chemotherapy, radiotherapy, immunology, and targeting；. 4.ECOG PS score: 0-2；. 6.Estimated survival time during screening is ≥ 12 weeks, and could be treated with current antitumor regimens for at least 1 cycle；.

The full record lists 8 inclusion and 22 exclusion criteria; among the exclusions: 1\. platelet values at screening or baseline were ≤10×10\^9/l；; 2.participants with a history of any hematological malignancy，including but not limited to leukemia, primary immune thrombocytopenia, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome；; 4.bone marrow invasion or metastasis;.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Romiplostim and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Romiplostim study: the participants and staff both knew the treatment.

It started in 2025-02-24 with completion listed for 2026-04-21.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 14 secondary outcomes, for example Thrombocytopenia level in X+1 cycle of antitumor therapy, Proportion of bleeding patients, The incidence of platelet transfusion and Effect of Romiplostim N01 on hemoglobin and leukocyte.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Romiplostim in 88 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, all human trials.