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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  08/22/2011
 
Trade Name:  Copegus and PEGASYS
 
Generic or Proper Name (*):  ribavirin and peginterferon alfa-2a
 
Indications Studied:  Treatment of chronic hepatitis C in patients 5 to 17 years of age
 
Therapeutic Category:  Antiviral
 
Ages Studied:  5-17 years
 
Study #:  1
 
Study Type:  Efficacy/Safety
 
Study Design:  Blind
 
No Patients:  114
 
No Centers:  11
 
No Countries:  1
 
BPCA(B), PREA(P):  P
 
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