Immunomodulation With Romiplostim in Young Adults With ITP

What Was Tested

The trial (phase 4) is built around Romiplostim.

The study aims to investigate immunomodulatory effects of thrombopoietin-receptor Agonist (TPO-RA) in patients with primary ITP, who failed first-line therapy or who became intolerant to it.

It is hypothesized that the early phase of this autoimmune disease may exhibit a stronger immunomodulatory potential in response to a stimulus, such as romiplostim.

Such a process may subsequently be capable to induce regulatory mechanisms or tolerance.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 15 actual participants took part.

It was open to people of any sex aged from 18 years up to 45 years.

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

Examples of who could join: Informed consent as documented by signature (see informed consent form). Primary ITP according to the definition of Rodeghiero et al. (52) and a platelet count of \<30x109/l. Age range: 18-45 years.

The full record lists 4 inclusion and 21 exclusion criteria; among the exclusions: platelet count higher than 30x109/l at time of screening; suspicion of secondary itp; positive family history for itp.

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 2016-04 with completion listed for 2019-07.

It ran at 5 sites in Switzerland (5).

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Romiplostim in 15 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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