Greenville, North Carolina 27834


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).


Inclusion Criteria: - Male, aged </= 12 years - Severe hemophilia A defined as < 1% FVIII:C - PTPs (previously treated patients) > 50 Exposure days (ED) with any FVIII products - PUPs (previously untreated patients) no prior exposure to any FVIII products - MTPs (minimally treated patients) not previously having received more than 3 Exposure Days (ED) with any FVIII products - No current evidence or history of inhibitory antibody Exclusion Criteria: - History of FVIII inhibitor formation - Diagnosed with other bleeding disorder - Platelet count < 100000 cells/μL - Kidney or liver dysfunction - Known hypersensitivity to any FVIII



Primary Contact:

Study Director
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Backup Contact:

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Location Contact:

Greenville, North Carolina 27834
United States

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Site Status: Recruiting

Data Source:

Date Processed: August 31, 2019

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