Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial

What Was Tested

The paper reports a study of Romiplostim, published as a randomized controlled trial.

The researchers assessed the long-term administration of romiplostim in splenectomised and non-splenectomised patients with ITP.

Who Took Part

The age groups tagged for this paper are adults, middle-aged adults and older adults, both men and women.

In two parallel trials, 63 splenectomised and 62 non-splenectomised patients with ITP and a mean of three platelet counts 30x10(9)/L or less were randomly assigned 2:1 to subcutaneous injections of romiplostim (n=42 in splenectomised study and n=41 in non-splenectomised study) or placebo (n=21 in both studies) every week for 24 weeks.

How the Study Was Run

The researchers set it up as a randomized, double-blind, placebo-controlled and parallel-group study.

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.

Blinding on both sides kept the participants and researchers unaware of who received Romiplostim.

Some participants received a placebo instead of Romiplostim, giving a reference point.

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

The timeline in the abstract includes 24 weeks.

These studies are registered with ClinicalTrials.gov, numbers NCT00102323 and NCT00102336.

What Was Measured

The researchers assessed the long-term administration of romiplostim in splenectomised and non-splenectomised patients with ITP.

PubMed files the paper under topics including Carrier Proteins, Chronic Disease, Platelet Count, Purpura, Thrombotic Thrombocytopenic, Receptors, Fc, Recombinant Fusion Proteins and Splenectomy.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Romiplostim over 24 weeks.

Its findings take up roughly 8 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2008 (Lancet (London, England)), a journal based in England.

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