Eltrombopag (platelet drug) Trial Halted

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.

http://tinyurl.com/2a734bb

[jusjames]

good info, thanks

[HectorSF]

Thanks Mike!

This is bad news for some persons who are stage 4 and have thrombocytopenia. I was hoping to/counting on being able to use eltrombopag.

My platelet count varies from 50,000 to 70,000 now. I was hoping to have eltrombopag to raise my platelets when I try to retreat when the new antiviral drugs come to market next year. During my first treatment in 2008 my platelets went from about 80,000 down below 20,000 after 12 weeks of treatment. Since I was a null responder I stopped treatment at that time. But my platelet count was becoming a concern to my doctors as it kept getting lower and lower the longer I treated. Since we still have to use peg-interferon, it seems likely this will happen again even if I clear the virus.

I believe the only option at this time is a blood transfusion during treatment to raise platelets.(?) Does anyone have different information or other options? I would appreciate hearing from you if you do.

"Portal vein thrombosis": Portal vein obstruction results from thrombosis (blood clot) or narrowing of the portal vein, which brings blood to the liver from the intestines. Portal vein thrombosis that develops in people with cirrhosis will cause their condition to deteriorate. Most people have no symptoms. Fluid may accumulate in the abdomen, the spleen may enlarge, and severe bleeding may occur in the esophagus. If possible, the cause is treated, and drugs may be used to prevent the clot from enlarging or to dissolve the clot.

HectorSF