A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A



Status:Completed
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any - 11
Updated:10/12/2018
Start Date:February 20, 2013
End Date:September 28, 2018

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This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and
pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP)
in children with severe haemophilia A who have undergone treatment with previous factor VIII
(FVIII) products.


Inclusion Criteria:

- Male patients with severe congenital haemophilia A (FVIII activity level below 1%)

- Weight above or equal to 10 kg - Documented history of 150 exposure days (ED) to FVIII
products for patients aged 6-11 years and above 50 ED to FVIII products for patients
aged 0-5 years

Exclusion Criteria:

- Any history of FVIII inhibitors
We found this trial at
24
sites
Philadelphia, Pennsylvania 19104
2373
mi
from 91732
Philadelphia, PA
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667
mi
from 91732
Boise, ID
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Boston, Massachusetts 02115
2576
mi
from 91732
Boston, MA
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Charleston, South Carolina 29407
2180
mi
from 91732
Charleston, SC
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Charlotte, North Carolina 28277
2101
mi
from 91732
Charlotte, NC
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Charlottesville, Virginia 22908
2208
mi
from 91732
Charlottesville, VA
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Cincinnati, Ohio 45229
1881
mi
from 91732
Cincinnati, OH
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Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
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1894
mi
from 91732
Dayton, OH
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Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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Iowa City, Iowa 52242
1528
mi
from 91732
Iowa City, IA
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Long Beach, California 90807
19
mi
from 91732
Long Beach, CA
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Minneapolis, Minnesota 55404
1509
mi
from 91732
Minneapolis, MN
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Nashville, Tennessee 37203
1762
mi
from 91732
Nashville, TN
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New Hyde Park, New York 11042
2449
mi
from 91732
New Hyde Park, NY
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New Orleans, Louisiana 70112
1655
mi
from 91732
New Orleans, LA
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Omaha, Nebraska 68114
1301
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from 91732
Omaha, NE
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Orange, California 92868
21
mi
from 91732
Orange, CA
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Orlando, Florida 32804
2182
mi
from 91732
Orlando, FL
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Phoenix, Arizona 85053
343
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from 91732
Phoenix, AZ
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Rio de Janeiro, 20211
?
mi
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Rio de Janeiro,
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Spokane, Washington 99202
939
mi
from 91732
Spokane, WA
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Tampa, Florida 33612
2134
mi
from 91732
Tampa, FL
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Washington, District of Columbia 20011
?
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Washington,
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