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The main purpose of this study is to gather information regarding the safety of ReFacto AF, and how well it works (effectiveness) in children with severe Hemophilia A under the age of 12. Approximatel...

Update Il y a 4 ans
Reference: EUCTR2008-008435-29

The main purpose of this study is to gather information regarding the safety of ReFacto AF, and how well it works (effectiveness) in children with severe Hemophilia A under the age of 12. Approximately 50 subjects, will take part in this study. 25 subjects will be 0-6 years of age and 25 subjects will be 6 to 12 years of age

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Extract

To evaluate the pharmacokinetics and incremental recovery of ReFacto AF in pediatric subjects less than 12 years of age after a single exposure to ReFacto AF.

Inclusion criteria

  • Severe hemophilia A (FVIII:C <1%) in male subjects <12 years of age

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