Romiplostim in Chemotherapy-Induced Thrombocytopenia

What Was Tested

The trial (phase 3) is built around Romiplostim.

It had two arms (groups): Interventional group (experimental) and Control group (no intervention).

Patients with CIT fulfilling the inclusion criteria randomized to the control group will not receive romiplostim injections. Patients are allowed to received supportive care according to the standard of care protocols.

The registry classes the interventions as drug.

Who Took Part

The registry lists 30 planned participants were the target.

It was open to people of any sex aged from 1 Year up to 18 years.

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

Examples of who could join: Severe thrombocytopenia either clinically with high bleeding score or laboratory by platelet count reaching critical level \< 20x10e9/L requiring platelet transfusion at time of chemotherapy cycle nadir.

The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: patients with second primary neoplasm; patients with relapsed/refractory solid malignancy; presence of primary or metastatic liver cancer.

How the Study Was Run

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

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

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

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

It started in 2023-12-17 with completion listed for 2025-05.

It ran at 1 site in Egypt.

Its stated primary purpose is supportive care.

What Was Measured

Researchers chose this as the main measure: Hematologic response (time frame: 12 weeks).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Romiplostim in 30 people.

Its size is small, so on its own it can only give an early look.

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.