* FDA says Promacta study in liver patients halted
Stocks | Global Markets | Healthcare
* Says more patients on drug got clots vs those on placebo
* Cautions drug not approved for those with liver disease (Previous dateline WASHINGTON)
By Ransdell Pierson
NEW YORK, May 12 (Reuters) - U.S. regulators said on Wednesday a study among liver-disease patients taking GlaxoSmithKline's (GSK.L)(GSK.N) Promacta treatment for low blood platelets was halted due to blood-clot safety issues.
The medicine is approved in the United States for treatment of chronic immune idiopathic thrombocytopenic purpura (ITP), a condition in which patients have abnormally low blood-platelet counts for no known cause -- putting them at risk of bruises or serious bleeding.
The U.S. Food and Drug Administration said the halted trial, called ELEVATE, involved patients whose low platelets were due to a known cause: 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 Promacta than those who received placebos.
Six patients, or 4 percent of patients receiving Promacta, and one patient, or 1 percent of those receiving placebos, experienced blood clots in an important blood vessel system that connects to the liver, called the Portal Venous System, the FDA said.
The FDA said it and Glaxo have reminded healthcare professionals that Promacta is not approved for treatment of patients with ITP that have chronic liver disease.
Platelets are one of the three main components of the blood, and are necessary for the normal blood-clotting process.
"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.
Promacta, approved by the FDA in late 2008 and developed in partnership with Ligand Pharmaceuticals Inc
Shares of Glaxo closed up 0.08 percent at $35.40 on the New York Stock Exchange. Ligand shares rose 3 cents to $1.69 on Nasdaq.
(Reporting by Ransdell Pierson; Additional reporting by Susan Heavey; Editing by Richard Chang)
Clinical trials.... ain't they a bitch!
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