Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Biopharm firm ZymoGenetics has begun a pivotal phase III clinical study of recombinant human thrombin as a tool for preventing blood loss in patients undergoing surgery.
Subscribe to our email newsletter
The study will compare the efficacy of recombinant human thrombin (rhThrombin) to bovine-derived thrombin and is designed to support broad product labeling for the use of rhThrombin as an aid to controlling blood loss during surgery.
The randomized, double-blinded phase III clinical trial with rhThrombin is being conducted at approximately 35 sites and will evaluate the same four types of surgery examined in phase II studies: spinal, liver resection, peripheral artery bypass and arteriovenous graft construction.
The primary objective of the trial is to assess efficacy by comparing the effectiveness of rhThrombin as a surgical hemostat to the currently approved bovine-derived thrombin, as measured by the incidence of hemostasis within 10 minutes.
The secondary objective is to evaluate safety, including testing for the formation of antibodies against rhThrombin or bovine-derived thrombin.
The study will enroll a minimum of 400 patients, approximately half of whom will receive rhThrombin.
“Patients need safer treatments for surgical bleeding. Because recombinant products can be manufactured to high levels of purity and don’t contain animal blood products, I believe rhThrombin could replace plasma-derived bovine thrombin,” said William Chapman, from the Washington University School of Medicine, and phase II clinical investigator.