Greenville, North Carolina 27834


Purpose:

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).


Criteria:

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


NCT ID:

NCT01311648


Primary Contact:

Study Director
Bayer Study Director
Bayer

Bayer Clinical Trials Contact
Email: clinical-trials-contact@bayer.com


Backup Contact:

For trial location information (Phone Menu Options '3' or '4')
Phone: (+)1-888-84 22937


Location Contact:

Greenville, North Carolina 27834
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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