Romiplostim, Rituximab and Dexamethasone as Frontline Treatment for Immune Thrombocytopenia

What Was Tested

This registered phase 2 trial tested Romiplostim.

It had 1 arm (groups): Romiplostim, Rituximab, Dexamethasone (experimental).

The registry classes the interventions as drug.

More on the Plan

Immune thrombocytopenia is an autoimmune disorder characterized by formation of autoantibodies against platelet antigens leading platelet destruction.

Debilitating side effects are common in patients who require long-term corticosteroid therapy to maintain the platelet count.

There are a few case reports where romiplostim an option as first line treatment for IT.

Duration of response is considered from the day of the initial administration to the first time of relapse (platelet count \<30×109/L) or to time of analysis Patients will be evaluated each week during 4 weeks and then every month for at least 6 months.

Who Took Part

12 planned participants were the target.

It was open to people of any sex aged from 16 years up to 90 years.

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

Examples of who could join: Clinically confirmed immune thrombocytopenia (IT) Platelet count less than 30,000/mm3 on two occasions. Subject ≥ 16 years. Subject has signed and dated written informed consent.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: performance status above or equal to 2; pregnancy and lactation; previous splenectomy.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Romiplostim study: the participants and staff both knew the treatment.

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

It started in 2020-11-01 with completion listed for 2021-11-01.

It ran at 1 site in Mexico.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Clinical Response (time frame: 28 days).

It also tracked 1 secondary outcome, for example Complete Response.

What This Means in Plain Language

Put simply, this is a phase 2 trial of Romiplostim in 12 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.