Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis

Phase 4

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
rThrombin, 1000 IU/mL	rThrombin, 1000 IU/mL	-

Primary Outcome Measures

Name	Time	Method
Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29	At baseline and Day 29	Immunogenicity of rThrombin product was evaluated using an enzyme-linked immunosorbent assay for detection of antirThrombin product antibody and a neutralizing antibody assay to characterize the potential of antibodies to rThrombin product to neutralize the activity of human plasma-derived thrombin.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Death as Outcome, Serious Adverse Events (SAEs), Treatment-related SAEs, Adverse Events (AEs), Treatment-related Adverse Events, and AEs Leading to Discontinuation	Baseline through Day 29, continuously	An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. Treatment-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
Number of Participants With AEs by Maximum Severity	Baseline to Day 29, continuously	An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. AE severity was assessed using Common Terminology Criteria for Adverse Events, Version 13.0: Grade 1=mild; Grade 2=moderate; Grade 3=severe; Grade 4=life-threatening; Grade 5=fatal.