• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail

  • Print
  • Share
  • E-mail
Approval Date:  10/10/2008
Trade Name:  Kogenate FS
Generic or Proper Name (*):  Antihemophilic Factor (Recombinant)*
Indications Studied:  Routine prophylaxis to reduce the frequency of bleeding episodes and the risk of joint damage in children with hemophilia A with no pre-existing joint damage
Therapeutic Category:  Hematology/Coagulation
Ages Studied:  0  2.5 years
Study #:  1
Study Type:  Efficacy/Safety
Study Design:  Open Label/Single-Blind/Parallel Group
No Patients:  65
No Centers:  14
No Countries:  1