A numerical increase in the rate of central nervous system (CNS) bleeding in the Xigris versus the placebo group was also noted in the early results of the trial.

Over the infusion period, the number of patients experiencing an intracranial hemorrhage event was 4 versus 1 for the overall population (Xigris vs. placebo), with 3 of the 4 events in the Xigris group occurring in patients aged 60 days or less.

Trial Stopped for Futility

The trial, called "Study F1K-MC-EVBP, Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis," is a randomized, double-blind, placebo-controlled trial of Xigris [drotrecogin alfa (activated)] in pediatric patients with severe sepsis.

"Xigris is not indicated for use in pediatric severe sepsis," says Paul Eisenberg, MD, Vice President, Global Product Safety, Eli Lilly, in the letter to physicians.

"The study’s external, independent Data Monitoring Committee (DMC) recommended that the trial be stopped for futility after a planned interim analysis showed that Xigris was highly unlikely to show an improvement over placebo in the primary endpoint of 'Composite Time to Complete Organ Failure Resolution' over 14 days, the letter continues.

No Benefit over Placebo

"Mortality, the rate of serious adverse events, overall serious bleeding events, and major amputations appeared to be similar in the Xigris and placebo groups," Dr. Eisenberg says.

"Data collection in study EVBP is ongoing. All patients enrolled will be followed for the complete 28-day study period. Full results of the data will be available in the latter part of 2005 and publicly presented as soon as possible," the letter states.