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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  10/10/2008
 
Trade Name:  Kogenate FS
 
Generic or Proper Name (*):  Antihemophilic Factor (Recombinant)*
 
Indications Studied:  Routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage
 
Therapeutic Category:  Hematology/Coagulation
 
Ages Studied:  0  2.5 years
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Open Label/Single-Blind/Parallel Group
 
No Patients:  65
 
No Centers:  14
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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