Immunogenicity and Safety Study of Topical Recombinant Thrombin in Surgical Hemostasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZymoGenetics
ClinicalTrials.gov Identifier:
NCT00491608
First received: June 22, 2007
Last updated: January 11, 2012
Last verified: January 2012
Results First Received: November 3, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Spinal Surgery
Vascular Surgery
Intervention: Biological: rThrombin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 234 participants enrolled, 209 received study drug. Of those who received study drug, 200 had both baseline and post-baseline immunogenicity evaluations.

Reporting Groups
  Description
rThrombin, 1000 IU/mL Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.

Participant Flow:   Overall Study
    rThrombin, 1000 IU/mL  
STARTED     209 [1]
COMPLETED     206  
NOT COMPLETED     3  
Death                 2  
Withdrawal by Subject                 1  
[1] Participants who received treatment



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
rThrombin Participants who received at least 1 application of rThrombin during spinal or vascular surgery (arterial reconstruction or PAB,or AV vascular access procedure and had seronegative baseline rThrombin antibody status

Baseline Measures
    rThrombin  
Number of Participants  
[units: participants]
  209  
Age, Customized  
[units: Years]
Median ( Full Range )
 
Overall (All status)     64  
  ( 30 to 89 )  
Gender  
[units: participants]
 
Female     99  
Male     110  
Race/Ethnicity, Customized  
[units: participants]
 
Hispanic     25  
Asian     2  
Black or African American     22  
White     160  



  Outcome Measures
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1.  Primary:   Number of Participants With Anti-recombinant Thrombin (rThrombin) Product Antibodies at Day 29 in Participants With and Without Anti-bovine Thrombin Product Antibodies at Baseline   [ Time Frame: At Day 29 ]

2.  Secondary:   Number of Participants With Death as Outcome, Serious Adverse Events, Treatment-related Adverse Events (AEs), and Treatment-emergent AEs   [ Time Frame: Day 1 (surgery) to Day 29 (end of study), continuously ]

3.  Secondary:   Number of Participants With Abnormal Hematology Laboratory Results of Common Terminology Criteria (CTC) Grade 2 or Higher at Baseline and Day 29   [ Time Frame: Baseline and Day 29 (end of study) ]

4.  Secondary:   Number of Participants With Elevations in Coagulation Parameters of CTC Grade 3 or Higher at Baseline and Day 29   [ Time Frame: Baseline and Day 29 (end of study) ]

5.  Secondary:   Number of Participants With Abnormal Laboratory Results in Median Levels of Immunoglobulin A, G, and M at Baseline or Day 29   [ Time Frame: Baseline and Day 29 (end of study) ]

6.  Secondary:   Number of Participants With Clinically Significant Changes in Mean Values for Vital Signs (Temperature, Systolic Blood Pressure, Diastolic Blood Pressure, Respiration Rate, Heart Rate) at Baseline and Day 29   [ Time Frame: Baseline and Day 29 (end of study) ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: John Pribble, Vice President, Medical Affairs; Scot Maxon, Scientific Information
Organization: ZymoGenetics, a Bristol-Myers Squibb company
phone: (206) 428-2756; (206) 434-3365
e-mail: John.Pribble@bms.com; Scot.Maxon@bms.com


No publications provided by ZymoGenetics

Publications automatically indexed to this study:

Responsible Party: ZymoGenetics
ClinicalTrials.gov Identifier: NCT00491608     History of Changes
Other Study ID Numbers: 499F04
Study First Received: June 22, 2007
Results First Received: November 3, 2011
Last Updated: January 11, 2012
Health Authority: United States: Food and Drug Administration