Regulatory

Promacta study in liver patients halted

Last Updated: 2010-05-12 19:52:22 -0400 (Reuters Health)

By Ransdell Pierson

NEW YORK (Reuters) - U.S. regulators said on Wednesday that a study among liver-disease patients taking GlaxoSmithKline's Promacta (eltrombopag) for low blood platelets was halted due to blood-clot safety issues.

The agent is approved in the United States for treatment of chronic immune idiopathic thrombocytopenic purpura (ITP).

The U.S. Food and Drug Administration said the halted trial, called ELEVATE, involved patients whose low platelets were due to liver damage. The agency, in a notice on its website, said the study was halted after a higher incidence of blood clots was seen in patients taking eltrombopag than those who received placebo.

Six patients, or 4% of those receiving eltrombopag, and one patient, or 1% of those receiving placebos, developed portal venous thrombosis, FDA said.

The FDA said it and Glaxo have reminded healthcare professionals that eltrombopag is not approved for treatment of patients with ITP who have chronic liver disease.

"Exercise caution when administering Promacta to patients with hepatic (liver) disease," the alert advised doctors, including use of a lower starting dose in patients with moderate to severe liver disease.