Clinical Trial: Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: ZymoGenetics

Current Primary Outcome: Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29 [ Time Frame: 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.


Original Primary Outcome: Incidence of anti-rThrombin product antibody development [ Time Frame: Day 29 ]

Current Secondary Outcome:

  • 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 [ Time Frame: 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 [ Time Frame: 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.


Original Secondary Outcome: Safety of rThrombin in subjects with prior exposure to rThrombin in clinical studies [ Time Frame: Through Day 29 ]

Information By: ZymoGenetics

Dates:
Date Received: December 19, 2008
Date Started: January 2009
Date Completion:
Last Updated: November 3, 2011
Last Verified: November 2011