Last updated on January 2020

BAY81-8973 Pediatric Safety and Efficacy Trial

Brief description of study

The primary objective is to evaluate the safety and efficacy of the treatment with BAY81-8973 for prophylaxis and treatment of breakthrough bleeds in children with severe hemophilia A.

The secondary objectives are

  • To assess the safety and efficacy of BAY81-8973 during surgeries.
  • To assess incremental recovery of BAY 81-8973.
  • To assess pharmacokinetic parameters in a subset of children. (PTPs and PUPs/MTPs -participation in pharmacokinetic [PK] sampling is voluntary and requires consent).

Clinical Study Identifier: NCT01311648

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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