GlaxoSmithKline plc has announced the initiation of a global, open-label, single group trial that will assess the efficacy, safety and tolerability of eltrombopag in patients previously treated for chronic thrombocytopenic purpura (ITP).

The trial, called REPEAT (Repeat ExPosure to Eltrombopag in Adults with Idiopathic Thrombocytopenic Purpura) will evaluate a repeated dosing schedule of three six week cycles of eltrombopag treatment in 50 patients with chronic ITP who will be enrolled at multiple centres.

"The current treatment approaches to acutely increase the platelet count typically include treatment with steroids or IV gammaglobulin - both of which may have issues with tolerability or safety," says James B Bussel, MD, director of the platelet disorders centre, children's blood foundation division at the New York-Presbyterian Hospital/Weill Cornell Medical Centre and investigator for this trial. "Due to patients' varying clinical circumstances, it is important to validate the safety and effectiveness of repeated short-term treatment with eltrombopag in patients with chronic ITP."

ITP is estimated to affect 50 to 100 new persons per million per year in the United States and Europe. People with ITP often bleed from small blood vessels underneath the skin causing bruises, nosebleeds, bleeding from the gums during dental work, or other bleeding that is difficult to stop. Bleeding in the brain or gastrointestinal (GI) tract is rare but can be life threatening if it occurs. Although this condition can be managed chronically, it is associated with significant mortality and morbidity 5 per cent of patients will die within ten years of diagnosis, primarily from intracranial haemorrhage.

"We are extremely encouraged by the continued progress in our eltrombopag clinical development programme", said Paolo Paoletti, MD, senior vice president, Oncology Medicine Development Centre, GSK. "We continue to be very optimistic about eltrombopag and we expect results from this trial will represent another step towards providing patients with a safer, more effective ITP treatment."