Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

What Was Tested

The trial (phase 2) is built around Romiplostim.

It had 1 arm (groups): Romiplostim N01 (experimental).

The registry classes the interventions as drug.

More on the Plan

The investigator had registered a clinical trial of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia（NCT04600960）.

The investigator will assess the changes of the platelet counts after the treatment of Romiplostim N01 from week 1 to week 24, and observe incidence of adverse events during the treatment of Romiplostim N01.

The investigator will complete the 4 weeks safety visits（once a week），if the subjects end or withdraw from the clinical trial.

Who Took Part

The registry lists 50 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 or above, gender not restricted;. Patients who have stopped chemotherapy and radiotherapy for more than 1 month;. Patients with platelet count at enrollment \< 30×10\^9/L;. Patients with platelet count remains \< 30×10\^9/L for more than 1 month;. Patients with expected survival period ≥ 6 months;.

The full record lists 10 inclusion and 14 exclusion criteria; among the exclusions: patients with poor compliance;; positive serology for hiv, hepatitis b virus (hbv), hepatitis c virus (hcv), and/or hepatitis d virus (hdv), syphilis; positive for epstein-barr virus dna, cytomegalovirus dna;; accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Romiplostim study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2025-08 with completion listed for 2026-08.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Efficiency after 12 weeks of treatment with Romiplostim N01 (time frame: 12 weeks).

It also tracked 5 secondary outcomes, for example Efficiency after 24 weeks of treatment with Romiplostim N01, Platelet counts at each visit point, WHO bleeding scale at each visit point and Adverse events.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Romiplostim in 50 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.