A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin

What Was Tested

The trial (phase 3) is built around Romiplostim.

A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin.

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

The registry classes the interventions as drug.

Who Took Part

60 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: Sign a written informed consent form before enrollment;. Age range from 18 to 75 years old;. Solid tumors or hematological tumors confirmed by tissue or pathology;. CTIT patients caused by anti-tumor therapy;. At least 2 weeks of treatment with two types of platelet growth factors and no response (including rhTPO or TPO-RA).

The full record lists 11 inclusion and 19 exclusion criteria; among the exclusions: bone marrow invasion or metastasis;; any history of arterial or venous thrombosis occurring within the first 6 months of screening;; screening for clinical manifestations of severe bleeding within the first two weeks, such as gastrointestinal or central nervous system bleeding;.

How the Study Was Run

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

Because people in this Romiplostim study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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 2024-06-01 with completion listed for 2025-06-01.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The proportion of patients with PLT ≥ 50 × 109/L within 4 weeks after receiving treatment (time frame: Within 4 weeks after receiving treatment).

It also tracked 6 secondary outcomes, for example The time required for PLT to recover to 50 × 109/L or above after treatment, The proportion of patients with PLT ≥ 50 × 109/L after 2 weeks of treatment, The proportion of patients with PLT ≥ 50 × 109/L after 12 weeks of treatment, The lowest platelet count from receiving treatment to the end of treatment, The proportion of patients receiving platelet transfusion and The proportion of restoring anti-tumor treatment for at least 2 cycles without recurrence of CTIT.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Romiplostim in 60 people.

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

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