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Pediatric Studies Characteristics - Detail
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Pediatrics
Pediatric Studies Characteristics
Detail
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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
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