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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  07/29/2008
 
Trade Name:  Cancidas
 
Generic or Proper Name (*):  caspofungin
 
Indications Studied:  Empirical therapy for presumed fungal infections in febrile, neutropenic patients; Candidemia and certain Candida infections; Esophageal Candidiasis; Invasive Aspergillosis in patients who are refractory to or intolerant of other therapies
 
Therapeutic Category:  Antifungal
 
Ages Studied:  2 - 17 years
 
Study #:  1
 
Study Type:  Safety/Pharmacokinetic
 
Study Design:  Open Label/Traditional Pharmacokinetic/Dose Response(1/3)
 
No Patients:  39
 
No Centers:  8
 
No Countries:  1
 
BPCA(B), PREA(P):  B, P
 
Asian:  0
 
Black:  3
 
Other:  12
 
White:  38
 
Native Hawaiian or Pacific Islander:  8
 
American Indian/Alaska Native:  5
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
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