Immunogenicity and Safety Study of rThrombin in Surgical Hemostasis - Full Text View

Purpose

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

Condition	Intervention	Phase
Blood Loss, Surgical	Biological: rThrombin, 1000 IU/mL	Phase 4

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Phase 4, Open-Label, Single-Group Immunogenicity and Safety Study of Re-exposure to RECOTHROM� (rThrombin) in Surgical Hemostasis

Resource links provided by NLM:

Drug Information available for: Thrombin Thrombin alfa

U.S. FDA Resources

Further study details as provided by ZymoGenetics:

Primary Outcome Measures:

Number or Participants With Antirecombinant Thrombin (rThrombin) Product Antibody at Baseline and Day 29 [ Time Frame: At baseline and Day 29 ] [ Designated as safety issue: No ]
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:

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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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.

Enrollment:	31
Study Start Date:	January 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: rThrombin, 1000 IU/mL	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. Other Name: RECOTHROM

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813904

Locations

United States, Arizona
Tuscon Orthopaedic Institute
Tuscon, Arizona, United States, 85712

Sponsors and Collaborators

ZymoGenetics

Investigators

Principal Investigator:

Neil Singla, MD

Lotus Clinical Research

More Information

No publications provided

Responsible Party:	ZymoGenetics
ClinicalTrials.gov Identifier:	NCT00813904 History of Changes
Other Study ID Numbers:	499G02
Study First Received:	December 19, 2008
Results First Received:	November 3, 2011
Last Updated:	November 3, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Hemorrhage
Blood Loss, Surgical
Pathologic Processes
Intraoperative Complications
Thrombin

Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013