Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia

What Was Tested

In this phase 3 trial, researchers set out to test Romiplostim.

Assess the immunogenicity of GP40141 in comparison with the drug Nplate®. 3.

It had two arms (groups): GP40141 (experimental) and Nplate (active comparator).

The registry classes the interventions as drug.

More on the Plan

The study will be conducted in adult patients with persistent or chronic primary immune thrombocytopenia.

Patients both naïve to treatment with a thrombopoietin receptor agonist (cohort 1) and those who have previously received therapy (cohort 2) will be included.

Cohort 1: Adult steroid-dependent or steroid-refractory patients with persistent or chronic primary immune thrombocytopenia (PIT) with or without a history of splenectomy who have not previously received thrombopoietin receptor agonist (TPO-RA) therapy.

Cohort 2: Adult patients with persistent or chronic primary immune thrombocytopenia receiving TPO-RA (romiplostim or eltrombopag) for ≥12 weeks and with sustained response status at screening.

Who Took Part

The registry lists 160 actual participants took part.

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: Signed informed consent to participate in the study. Male or female. Age ≥18 years. Diagnosis of primary immune thrombocytopenia (PIT). Duration of PIT at the Screening Visit: for cohort 1: ≥3 months; for cohort 2: ≥6 months.

The full record lists 10 inclusion and 33 exclusion criteria; among the exclusions: hypersensitivity to romiplostim; history of tpo-ra use: for cohort 1: any tpo-ra; for cohort 2: any tpo-ra, with the exception of romiplostim and eltrombopag; splenectomy \<24 weeks prior to the screening visit or planned splenectomy during the study.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

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.

The Romiplostim group and the comparison group ran side by side rather than switching.

In this single-blind Romiplostim study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2023-04-04 with completion listed for 2028-03-31.

It ran at 6 sites in Russia (6).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: Proportion of subjects with platelet response (time frame: 10 weeks). Number of adverse events (AEs) (time frame: 10 weeks). Proportion of subjects experiencing AEs, (time frame: 10 weeks).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Romiplostim in 160 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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