Table 1.

Pharmacodynamics of rFXIII


Dose, U/kg

Increased activity, %

Response, %/U/kg
20   
Patient 5   57   2.9  
Patient 6   59   3.0  
50   
Patient 7   105   2.1  
Patient 8   122   2.4  
Patient 9   129   2.6  
75   
Patient 10   181   2.4  
Patient 11
 
160
 
2.1
 

Dose, U/kg

Increased activity, %

Response, %/U/kg
20   
Patient 5   57   2.9  
Patient 6   59   3.0  
50   
Patient 7   105   2.1  
Patient 8   122   2.4  
Patient 9   129   2.6  
75   
Patient 10   181   2.4  
Patient 11
 
160
 
2.1
 

FXIII activity was measured and percentage increase in FXIII activity per unit per kilogram was calculated after a single dose of 20, 50, or 75 U/kg rFXIII. Patient 6 had normal levels of FXIII before dose, so data were baseline corrected before pharmacokinetic analyses. Patient 7 had FXIII B subunit deficiency.

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