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news.GlaxoSmithKline has commenced a worldwide phase III clinical trial to investigate the safety and efficacy of eltrombopag, as a once-daily orally-administered drug for adult patients who have been previously treated for the cardiovascular disorder idiopathic thrombocytopenic purpura.
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ITP is a disorder characterized by low platelet counts leaving patients at risk of episodes of spontaneous bruising, mucosal bleeding, and in severe cases intracranial hemorrhage.
The multicenter phase III study, has a double-blind, randomized, placebo-controlled, parallel group design. Subjects will be randomized to receive eltrombopag or placebo once daily for six weeks.
The study population will comprise adults with ITP, diagnosed at least six months prior to screening, who have platelet counts lower than 30,000/uL and who have not responded to previous treatment or have relapsed within three months of previous treatment.
Those who achieve a platelet count of more than 50,000/uL after 42 days of dosing will be considered treatment responders. Safety and quality of life outcomes also will be assessed.
“Data to date demonstrates that eltrombopag may be effective in increasing platelet counts in patients with chronic ITP and this trial will help us to further evaluate its potential,” said Dr Paolo Paoletti, senior vice president, Oncology Medicine Development Centre, GSK.