ZYMOGENETICS STARTS RHTHROMBIN STUDY

ZymoGenetics has started a Phase III trial of recombinant human Thrombin (rhThrombin) in surgery patients. The randomized, double-blinded study will enroll at least 400 patients at 35 sites, evaluating rhThrombin in four types of surgery: spinal, liver resection, peripheral artery bypass and arteriovenous graft construction.

The trial will compare the efficacy of rhThrombin to bovine-derived thrombin, the current standard of care, and is designed to support broad product labeling of rhThrombin to control blood loss during surgery. The primary objective is to compare the two products by the incidence of hemostasis within 10 minutes. Secondary endpoints will look at safety, as well as testing for the formation of antibodies against each of the two products.

In the trial, researchers expect to use validated assays to look at antibody reactions to each product. The marketed version of thrombin is derived from bovine plasma, which brings with it impurities that cause the formation of antibodies that cross-react with human blood proteins, leading to serious bleeding complications.