Novo Nordisk terminates Phase III trauma trial

The decision was made based on the results of an analysis for futility conducted by the independent data monitoring committee. Due to an observed lower mortality than anticipated in the overall study group (around 10% in the Phase III trial in total compared to more than 25% in the Phase II trial), a futility analysis was conducted to assess the likelihood of reaching a successful outcome on the primary endpoint.

The analysis predicted a low likelihood of obtaining a positive trial outcome with the planned study population, and as a consequence, Novo Nordisk has decided to discontinue the trial.

The study had enrolled more than 550 patients of the planned 1,502 in 24 countries. It was a multicenter, randomized, double-blind, parallel group, placebo-controlled trial to evaluate the efficacy and safety of NovoSeven in severely injured trauma patients with bleeding refractory to standard treatment. Randomized patients received three single doses of NovoSeven (200mcg/kg + 100mcg/kg + 100mcg/kg) or placebo after the transfusion of the fourth unit of red blood cells).

The study has the primary endpoint of all cause 30-day mortality designed to show superiority of NovoSeven compared to placebo in blunt trauma patients. If not superior, the endpoint included an analysis to demonstrate non-inferiority of NovoSeven compared to placebo on all cause 30-day mortality and superiority of NovoSeven compared to placebo on pulmonary and/or renal dysfunction requiring ongoing medical intervention at day 30 in blunt trauma patients.