Thrombocytopenia Trial Halted
By Kristina Fiore, Staff Writer, MedPage Today
Published: May 13, 2010
WASHINGTON -- Drugmaker GlaxoSmithKline terminated a trial of eltrombopag (Promacta) in liver disease patients due to an increase in thrombotic events in the treatment group, the FDA said.
Six patients (4%) taking eltrombopag had a thrombosis of the portal venous system compared with one patient (1%) on placebo, the company said in a letter to healthcare professionals.
The findings, which were reported at the European Association for the Study of the Liver meeting in April, emerged from an analysis of the ELEVATE Study, a randomized, double-blind, placebo-controlled, multicenter trial.
In the trial, patients with thrombocytopenia due to chronic liver disease were randomized to eltrombopag 75mg or matching placebo for 14 days prior to an elective invasive procedure.
The drug is a thrombopoietin receptor agonist and is approved for the treatment of thrombocytopenia in adult patients.
The researchers found an imbalance of thrombosis of the portal venous system in treated patients compared with those on placebo.
Among the six patients in the eltrombopag group who had a portal venous thrombosis, five had it at platelet counts above 200,000/μL, the company said.
GlaxoSmithKline has notified the clinical trial investigators and regulatory agencies and is working with regulatory agencies to add safety information to the label.
The FDA said the drug is indicated for the treatment of thrombocytopenia in adult patients with chronic immune idiopathic thrombocytopenic purpura and is not indicated for the treatment of thrombocytopenia in patients with chronic liver disease.
The agency also added that treatment should be aimed at increasing the platelet count to a level that reduces the risk of bleeding and shouldn't be used in an attempt to normalize the platelet count.
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