Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis

A Phase 4, Open-Label, Single-Group Immunogenicity and Safety Study of Re-exposure to RECOTHROM� (rThrombin) in Surgical Hemostasis

The objective of this study is to assess the immunogenicity and safety of recombinant Thrombin (rThrombin) in patients with prior rThrombin exposure.

The safety, immunogenicity, and efficacy of rThrombin have been evaluated in Phase 2 and Phase 3 studies in the following surgical indications: spinal surgery, major hepatic resection, peripheral arterial bypass (PAB) surgery, arteriovenous (AV) graft formation for hemodialysis access, and skin graft surgery following burn injury. Limited data on rThrombin reexposure currently exist. This study will assess the immunogenicity and safety of rThrombin in participants who are undergoing a surgical procedure during which topical rThrombin application is planned and who previously received rThrombin in Phase 3 clinical trials or during prior spine, AV graft formation, or PAB surgical procedures.

Inclusion Criteria:

• Previous enrollment in a ZymoGenetics-sponsored Phase 3 study and the recipient of treatment with rThrombin in that study or the recipient of commercially-available rThrombin in a prior spine, arteriovenous graft formation, or peripheral artery bypass surgical procedure
• Age of 18 years or older at time of consent
• Bleeding indicating treatment with rThrombin during the course of the surgical procedure
• Signed informed consent document approved by an institutional review board or independent ethics committee

Exclusion Criteria:

• Currently undergoing a procedure requiring cardiopulmonary bypass or involving the aortic arch
• Known hypersensitivity to rThrombin product or any of its components
• Currently undergoing a surgical procedure where the use of other thrombin-containing hemostatic agents is planned
• Medical, social, or psychosocial factors that, in the opinion of the investigator, could affect the participant's safety or compliance with study procedures
• Treatment with any experimental agent within 30 days of study enrollment or treatment