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Safety and Immunogenicity Study of Recombinant Thrombin (rThrombin) in Pediatric Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ZymoGenetics
ClinicalTrials.gov Identifier:
NCT00859547
First received: March 9, 2009
Last updated: January 25, 2012
Last verified: January 2012
History of Changes
Results First Received: November 3, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Blood Loss, Surgical
Intervention: Biological: rThrombin, 1000 IU/mL

  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
Of the 32 participants who signed informed consent in this study, 30 were actually enrolled and received treatment with rThrombin.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
rThrombin, 1000 IU/mL Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.

Participant Flow:   Overall Study
    rThrombin, 1000 IU/mL  
STARTED     30  
COMPLETED     28  
NOT COMPLETED     2  
Lost to Follow-up                 1  
Parent withdrew consent                 1  



  Baseline Characteristics
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Reporting Groups
  Description
rThrombin, 1000 IU/mL Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.

Baseline Measures
    rThrombin, 1000 IU/mL  
Number of Participants  
[units: participants]
 		  30  
Age, Customized  
[units: participants]
 		 
0-2 years     11  
3-6 years     8  
7-11 years     3  
12-17 years     8  
Gender  
[units: participants]
 		 
Female     12  
Male     18  
Race/Ethnicity, Customized  
[units: participants]
 		 
American Indian/Alaskan native     1  
Black or African American     6  
Hispanic     9  
White     14  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Death, Serious Adverse Events, Treatment-related Adverse Events (AE), AEs Leading to Discontinuation, and AEs of Hypersensitivity   [ Time Frame: Days 1 through 29, continuously ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With AEs by Maximum Severity   [ Time Frame: Days 1 through 29, continuously ]
  Show Outcome Measure 2

3.  Primary:   Number of Participants With Clinical Laboratory Findings of Grade O or Higher in Platelet, White Blood Cell (WBC), Lymphocyte, and Neutrophil Counts   [ Time Frame: Baseline and Day 29 from Baseline ]
  Show Outcome Measure 3

4.  Primary:   Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels   [ Time Frame: Baseline and Day 29 from Baseline ]
  Hide Outcome Measure 4

Measure Type Primary
Measure Title Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels
Measure Description LLN=lower level of normal. Grade 1=100 g/L to <LLN; Grade 2=80 to <100 g/L; Grade 3=65 to <80 g/L; Grade 4=<65 g/L.
Time Frame Baseline and Day 29 from Baseline  
Safety Issue Yes  

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.
Participants who received treatment with rThrombin.

Reporting Groups
  Description
rThrombin, 1000 IU/mL Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.

Measured Values
    rThrombin, 1000 IU/mL  
Number of Participants Analyzed  
[units: participants]
 		  30  
Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels  
[units: Participants]
 		 
Grade 1 low hemoglobin (Baseline)     13  
Grade 1 low hemoglobin (Day 29, N=26)     7  
Grade 2 low hemoglobin (Baseline)     4  
Grade 2 low hemoglobin (Day 29, N=26)     5  
Grade 3 low hemoglobin (Baseline)     1  
Grade 3 low hemoglobin (Day 29, N=26)     0  
Grade 4 low hemoglobin (Baseline)     0  
Grade 4 low hemoglobin (Day 29, N=26)     0  

No statistical analysis provided for Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Hemoglobin Levels



5.  Primary:   Number of Participants With Clinical Laboratory Findings of Grade 0 or Higher in Creatinine Levels   [ Time Frame: Baseline and Day 29 from Baseline ]
  Show Outcome Measure 5

6.  Primary:   Number of Participants With Elevations in the Coagulation Parameter of Activated Partial Thromboplastin Time (aPPT)of Grade 0 or Higher   [ Time Frame: Baseline and Day 29 from Baseline ]
  Show Outcome Measure 6

7.  Primary:   Number of Participants With a High International Normalized Ratio (INR) of Prothrombin Time of Grade 0 or Higher   [ Time Frame: Baseline and Day 29 from Baseline ]
  Show Outcome Measure 7

8.  Secondary:   Number of Participants WIth Positive Findings for Anti-rThrombin Product Antibody   [ Time Frame: At Day 29 ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  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
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: NCT00859547     History of Changes
Other Study ID Numbers: 499H01
Study First Received: March 9, 2009
Results First Received: November 3, 2011
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board