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A Study of the Use of Factor XIII Concentrate in Patients With Inherited FXIII Deficiency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSL Behring
ClinicalTrials.gov Identifier:
NCT00883090
First received: April 16, 2009
Last updated: December 7, 2011
Last verified: December 2011
History of Changes
Results First Received: December 7, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Factor XIII Deficiency
Intervention: Biological: FXIII Concentrate (Human)

  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
One subject was not administered FXIII because of the Sponsor's decision. This subject was not included in the analyses.

Reporting Groups
  Description
FXIII All subjects treated with Factor XIII Concentrate (Human) (FXIII)

Participant Flow:   Overall Study
    FXIII  
STARTED     15 [1]
COMPLETED     13  
NOT COMPLETED     2  
Sponsor's decision                 1  
Withdrawal by Subject                 1  
[1] Of the 15 participants started, 14 were administered FXIII



  Baseline Characteristics
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Reporting Groups
  Description
FXIII All subjects treated with Factor FXIII Concentrate (Human) (FXIII)

Baseline Measures
    FXIII  
Number of Participants  
[units: participants]
 		  14  
Age  
[units: years]
Mean ± Standard Deviation 		  24.0  ± 12.55  
Gender  
[units: participants]
 		 
Female     7  
Male     7  



  Outcome Measures
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1.  Primary:   Peak FXIII Concentration at Steady State   [ Time Frame: 12 weeks ]
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2.  Primary:   Trough FXIII Concentration at Steady State   [ Time Frame: 12 weeks ]
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3.  Primary:   Time to Peak Concentration   [ Time Frame: 12 weeks ]
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4.  Primary:   Incremental Recovery   [ Time Frame: 12 weeks ]
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5.  Primary:   Terminal Half-life   [ Time Frame: 12 weeks ]
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6.  Primary:   Area Under the Curve at Steady State   [ Time Frame: 12 weeks ]
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7.  Primary:   Clearance   [ Time Frame: 12 weeks ]
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8.  Primary:   Volume of Distribution at Steady State   [ Time Frame: 12 weeks ]
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9.  Primary:   Mean Residence Time   [ Time Frame: 12 weeks ]
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10.  Secondary:   Adverse Events   [ Time Frame: 16 weeks ]
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11.  Secondary:   Laboratory Safety Parameters   [ Time Frame: 16 weeks ]
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12.  Secondary:   Vital Signs   [ Time Frame: 16 weeks ]
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Measure Type Secondary
Measure Title Vital Signs
Measure Description Number of participants with clinically significant vital signs. The vital signs measured included blood pressure, pulse rate and temperature. Clinically significant changes in vital signs were to be reported as adverse events.
Time Frame 16 weeks  
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.
The analysis population was the safety population. The safety population comprised all subjects who received a dose of Factor XIII.

Reporting Groups
  Description
FXIII All subjects treated with Factor FXIII Concentrate (Human) (FXIII)

Measured Values
    FXIII  
Number of Participants Analyzed  
[units: participants]
 		  14  
Vital Signs  
[units: participants]
 		  0  

No statistical analysis provided for Vital Signs




  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: Clinical Trial Disclosure Manager
Organization: CSL Behring
phone: Use email contact
e-mail: clinicaltrials@cslbehring.com


No publications provided


Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT00883090     History of Changes
Other Study ID Numbers: BI71023_2002, 2009-010387-41, 1479
Study First Received: April 16, 2009
Results First Received: December 7, 2011
Last Updated: December 7, 2011
Health Authority: United States: Food and Drug Administration
Spain: Comité Ético de Investigación Clínica