BAY81-8973 Pediatric Safety and Efficacy Trial



Status:Recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any - 12
Updated:3/23/2019
Start Date:June 9, 2011
End Date:December 31, 2022
Contact:Bayer Clinical Trials Contact
Email:clinical-trials-contact@bayer.com

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A Multicenter Phase III Uncontrolled Open-label Trial to Evaluate Safety and Efficacy of BAY81-8973 in Children With Severe Hemophilia A Under Prophylaxis Therapy

The objective of the study is to demonstrate the safety and efficacy of treatment with
BAY81-8973 for prophylaxis and breakthrough bleeds in children with severe haemophilia A.


Inclusion Criteria:

- Male, aged
- Severe hemophilia A defined as < 1% FVIII:C

- PTPs (previously treated patients) > 50 Exposure days (ED) with any high purity FVIII,
or

- PUPs (previously untreated patients) no prior exposure to any high purity FVIII

- MTPs (minimally treated patients) not previously having received more than 3
injections with any FVIII concentrate

- 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
We found this trial at
10
sites
Greenville, North Carolina 27834
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Greenville, NC
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Bahia Blanca,
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Charleston, South Carolina 29412
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Charleston, SC
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Chattanooga, TN
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Cincinnati, OH
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Cleveland, OH
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Columbus, OH
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East Lansing, MI
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Louisville, KY
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New Orleans, LA
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