Evaluation of bleeding and thrombotic events during long-term use of romiplostim in patients with chronic immune thrombocytopenia (ITP)

What Was Tested

Researchers studied Romiplostim in this randomized controlled trial publication.

To evaluate bleeding and thrombotic events occurring in chronic ITP patients during two phase 3, randomized, placebo-controlled, 24-week studies of romiplostim and during subsequent treatment in an open-label extension study.

Why It Was Studied

Romiplostim is a peptibody protein that raises platelet counts during long-term treatment of patients with chronic immune thrombocytopenia (ITP).

Who Took Part

The abstract describes 125 patients taking part.

Patients who completed the phase 3 trials could enroll in the extension study in which all patients received romiplostim.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Romiplostim and who got the comparison, which limits bias.

As a double-blind Romiplostim study, the assignments were hidden from both participants and investigators until the end.

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

The comparison arm used a placebo, so changes seen with Romiplostim could be set against what happens without it.

What Was Measured

Topics PubMed links to this paper include Chronic Disease, Hemorrhage, Receptors, Fc, Receptors, Thrombopoietin, Recombinant Fusion Proteins, Thrombocytopenia and Thrombopoietin.

What This Means in Plain Language

The paper is a randomized, double-blind and open-label study of Romiplostim in 125 patients.

Results are reported in around 4 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2010 (Journal of thrombosis and haemostasis : JTH), a journal based in England.

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