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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  12/11/2008
 
Trade Name:  PegIntron
 
Generic or Proper Name (*):  Peginterferon alfa-2b
 
Indications Studied:  Co-administered with ritonavir to treat chronic hepatitis C in patients 3 years of age and older with compensated liver disease previously untreated with interferon alpha
 
Therapeutic Category:  Antiviral
 
Ages Studied:  3 - 17 years
 
Study #:  1
 
Study Type:  Efficacy/Safety/Pharmacokinetic/Tolerability
 
Study Design:  Open Label/Traditional Pharmacokinetic
 
No Patients:  107
 
No Centers:  22
 
No Countries:  9
 
BPCA(B), PREA(P):  P
 
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