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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  08/28/2009
 
Trade Name:  Valcyte
 
Generic or Proper Name (*):  valganciclovir
 
Indications Studied:  Prevention of cytomegalovirus (CMV) disease in pediatric kidney and heart transplant patients e 4 months of age
 
Therapeutic Category:  Antiviral
 
Ages Studied:  3 months - 16 years
 
Study #:  3
 
Study Type:  Safety/Pharmacokinetic
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  63
 
No Centers:  1
 
No Countries:  1
 
BPCA(B), PREA(P):  B, P
 
Asian:  2
 
Black:  1
 
Other:  7
 
White:  51
 
Native Hawaiian or Pacific Islander:  2
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  22
 
Non-Hispanic/Non Latino:  41
 
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