Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis

Blood Loss, Surgical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813904
• Other study ID #: 499G02
• Status: Completed
• Phase: Phase 4
• First received: December 19, 2008
• Last updated: November 3, 2011
• Start date: January 2009
• Est. completion date: July 2010

Study information

• Verified date: November 2011
• Source: ZymoGenetics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss, Surgical

Intervention

Biological:
• rThrombin, 1000 IU/mL
At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site, per product labeling.

Locations

Country	Name	City	State
United States	Tuscon Orthopaedic Institute	Tuscon	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
ZymoGenetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody 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.	At baseline and Day 29	No
Secondary	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	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.	Baseline through Day 29, continuously	Yes
Secondary	Number of Participants With AEs by Maximum Severity	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.	Baseline to Day 29, continuously	Yes