Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.



Status:Active, not recruiting
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any - 12
Updated:2/10/2019
Start Date:May 16, 2012
End Date:November 30, 2023

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Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B

This trial is conducted in Asia, Europe and North America. The aim of the trial is to
evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body)
of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with
Haemophilia B.


Inclusion Criteria:

- Male patients with moderately severe or severe congenital haemophilia B with a Factor
IX activity level below or equal to 2% according to medical records

- Age below or equal to 12 years (until patient turns 13 years, at time of inclusion)

- Body weight above or equal to 10 kg

- History of at least 50 exposure days (EDs) to other FIX products

- The patient and/or parent(s)/caregiver are capable of assessing a bleeding episode,
keeping an electronic diary (eDiary), capable of conducting home treatment and
otherwise able to follow trial procedures

Exclusion Criteria:

- Known history of FIX inhibitors

- Current FIX inhibitors above or equal to 0.6 Bethesda Units (BU)

- Congenital or acquired coagulation disorder other than haemophilia B

- Platelet count below 50,000/mcL at screening

- Alanine aminotransferase (ALT) above 3 times the upper limit of normal reference
ranges at screening

- Creatinine level above or equal to 1.5 times above the upper normal limit of normal
reference ranges at screening

- Human immunodeficiency virus (HIV) positive, defined by medical records, and with a
CD4+ lymphocyte count below or equal to 200/mcL

- Immune modulating or chemotherapeutic medication (except single pulse treatment,
inhaled and topical steroids)

- Previous arterial thrombotic events (myocardial infarction and intracranial
thrombosis, as defined by medical records)
We found this trial at
17
sites
Omaha, Nebraska 68114
1301
mi
from 91732
Omaha, NE
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Augusta, Georgia 30912
2059
mi
from 91732
Augusta, GA
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Brooklyn, New York 11215
2186
mi
from 91732
Brooklyn, NY
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Cleveland, Ohio 44106
2032
mi
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Cleveland, OH
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Curitiba, Parana 80250
?
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Curitiba,
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Dallas, Texas 75231
1225
mi
from 91732
Dallas, TX
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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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Kansas City, Missouri 64106
1341
mi
from 91732
Kansas City, MO
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Miami, Florida 33136
2321
mi
from 91732
Miami, FL
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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 Brunswick, New Jersey 08903
2410
mi
from 91732
New Brunswick, NJ
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New York, New York 10029
2435
mi
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New York, NY
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Oklahoma City, Oklahoma 73112
1165
mi
from 91732
Oklahoma City, OK
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Philadelphia, Pennsylvania 19104
2373
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Philadelphia, PA
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Washington, District of Columbia 20011
?
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Washington,
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