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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/19/2007
 
Trade Name:  Hepsera
 
Generic or Proper Name (*):  adefovir dipivoxil
 
Indications Studied:  Chronic hepatitis B virus infection
 
Therapeutic Category:  Antiviral
 
Ages Studied:  2-18 years
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  173
 
No Centers:  26
 
No Countries:  6
 
BPCA(B), PREA(P):  B, P
 
Asian:  41
 
Black:  14
 
Other:  6
 
White:  111
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  1
 
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