OMRIX ANNOUNCES POSITIVE DATA ON HUMAN THROMBIN
Omrix Biopharmaceuticals has announced positive results from its Phase III pivotal clinical trial of human thrombin in achieving hemostasis in general surgery procedures. The non-inferiority clinical trial evaluated the equivalence of topical human thrombin to bovine thrombin in terms of safety and efficacy. All primary endpoints were met, and the company plans to file a biologics license application in November.
The multicenter, prospective, randomized, controlled, double-blinded trial was conducted at 22 sites in the U.S. in subjects undergoing elective surgical procedures, including cardiovascular surgery, neurologic (spine) procedures and general surgery or post-traumatic procedures. A total of 305 patients were randomized to receive either human thrombin, the investigational product, or bovine thrombin, the control. Approximately half (153) of the patients received human thrombin. The study was designed to support broad product labeling for the use of thrombin as an aid to control bleeding during surgery.
The primary endpoint of the clinical trial evaluated the equivalence of topical human thrombin to bovine thrombin in terms of efficacy as determined by the success in achieving hemostasis within 10 minutes of product application in subjects undergoing elective surgical procedures. The study met its primary endpoint, with both human and bovine thrombin achieving hemostasis within 10 minutes 97.4 percent of the time.
The secondary endpoint of the clinical trial measured the success in achieving hemostasis at three and six minutes after product application. Overall, the study met its secondary endpoints, with human thrombin achieving hemostasis within three minutes 73.2 percent of the time, and within six minutes 94.8 percent of the time, and with bovine thrombin achieving hemostasis within three minutes 72.4 percent of the time, and within six minutes 92.8 percent of the time.
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