Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
  • Print
  • Share
  • E-mail
-
 
Approval Date:  12/14/2011
 
Trade Name:  Advate
 
Generic or Proper Name (*):  Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method*
 
Indications Studied:  Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children (0-16 years) with hemophilia A
 
Therapeutic Category:  Antihemophilic Factor
 
Ages Studied:  7 - 59 year
 
Study #:  1
 
Study Type:  Efficacy/Safety/Pharmacokinetic
 
Study Design:  Randomized/Open label, Controlled
 
No Patients:  73
 
No Centers:  30
 
No Countries:  10
 
BPCA(B), PREA(P):  P
 
Asian:  0
 
Black:  0
 
Other:  0
 
White:  0
 
Unknown:  0
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
Countries:  0
 
-
-