Clinical Trial Overview for rThrombin

American Burn Assoc. RECOTHROM spray results
ASH rThrombin Poster

rThrombin Phase 3b

In the second quarter of 2007, the company initiated a Phase 3b open-label, multi-site clinical trial with rThrombin to evaluate approximately 200 subjects undergoing spinal or vascular surgery. The study is designed to gather information to validate the strong safety profile of rThrombin.

rThrombin Phase 3 completed

ZymoGenetics completed a pivotal Phase 3 clinical study of recombinant Thrombin (rThrombin) in patients undergoing surgery. Results were presented in September 2006. The study compared the efficacy of rThrombin to bovine-derived thrombin and was designed to support broad product labeling for the use of rThrombin as an aid to controlling blood loss during surgery. The Phase 3 study showed that rThrombin had comparable efficacy and a superior immunogenicity profile compared to the marketed bovine thrombin product. In December 2006, ZymoGenetics submitted a Biologics License Application (BLA) for rThrombin to the FDA.

If you're interested in learning more about clinical trials with rThrombin, please contact us at: clinicaltrials@zgi.com. For more information about rThrombin Product Backgrounder: http://www.zymogenetics.com/products/rhthrombin.html
	3-D representation of recombinant Thrombin protein structure

Related Press Releases

FDA Approves ZymoGenetics' RECOTHROM(TM) Thrombin, topical (Recombinant)

ZymoGenetics Provides Update on rhThrombin Development Plans

FDA Accepts ZymoGenetics' Recombinant Human Thrombin Application for Review

ZymoGenetics Submits Biologics License Application to the FDA for rhThrombin as an Aid to Controlling Bleeding During Surgery

ZymoGenetics Discusses Detailed Results From Successful Phase 3 Trial Evaluating rhThrombin as a Potential Treatment for Surgical Bleeding

ZymoGenetics Reports Positive Results From Pivotal Phase 3 Clinical Trial of rhThrombin

ZymoGenetics Completes Enrollment for rhThrombin Phase 3 Trial

ZymoGenetics Begins Phase 3 Clinical Study with Recombinant Human Thrombin

Summary Results of Phase 2 Clinical Trials with Recombinant Human Thrombin

ZymoGenetics to Begin Clinical Studies with Recombinant Human Thrombin

Scientific Publications:
http://www.zymogenetics.com/research/publication.html

THROMBIN QUICK FACTS