Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia

What Was Tested

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

It had two arms (groups): romiplostim plus dexamethasone (ROM + DEX) (experimental) and Dexamethasone (DEX) (active comparator).

The registry classes the interventions as drug.

More on the Plan

Maximum time on treatment with romiplostim will be 12 months (365 days).

Then, patients will be followed up for 6 additional months (180 days) after stopping romiplostim.

Who Took Part

129 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: Age ≥ 18 years of age at the time of signing informed consent. Newly diagnosis of primary ITP according to the International Working Group assessment \[1\] and previously untreated for ITP. Platelet counts \<30x109/L or ITP with platelet counts \<50x109/L and concomitant bleeding symptoms.

The full record lists 4 inclusion and 26 exclusion criteria; among the exclusions: world health organization's performance status \>2; previous use of romiplostim, polyethylene glycol-recombinant human megakaryocyte growth and development factor, eltrombopag, recombinant human anti-thrombopoietin, or any platelet-producing agent three months before enrolment; alkylating agents within 8 weeks before the screening visit or anticipated use during the time of the proposed study.

How the Study Was Run

The set-up was 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.

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

Everyone knew when Romiplostim was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2022-12-02 with completion listed for 2026-10-24.

It ran at 30 sites in Spain (15), United Kingdom (9) and Italy (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Proportion of patients achieving sustain response out of treatment with platelets higher or equal than 30x109/L for 6 months (Sustained Response Off any ITP Treatment) (time frame: 180 days after treatment withdrawal).

It also tracked 27 secondary outcomes, for example Proportion of patients with early response (ER), Proportion of patients with initial response (IR), Proportion of patients with complete response (CR), Proportion of patients with response (R), Proportion of patients with global response (GR) and Proportion of patients with targeted range (TR).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Romiplostim in 129 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.