A Research Study Looking at How a Factor VIII Medicine Called Turoctocog Alfa Pegol (N8-GP) Works in People With Haemophilia A



Status:Enrolling by invitation
Conditions:Hematology, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:Any
Updated:3/24/2019
Start Date:April 30, 2018
End Date:December 3, 2020

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Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Prophylaxis and Treatment of Bleeds in Previously N8-GP Treated Patients With Severe Haemophilia A

This study will look at how a known study medicine N8-GP works in previously N8-GP treated
people with haemophilia A. The aim is to look at how N8-GP works during regular use.
Participants will get N8-GP. N8-GP has been tested in more than 200 people with haemophilia A
for several years. Participants will get an injection of N8-GP into a blood vessel, one, two
or three times weekly. Participants will get more doses if they bleed or if they will need a
surgery. The study will last for about 2 years. Participants will have at least 9 visits with
the study doctor. If participants agree to be in this study, they will get their first
injection (in this study) at the first visit. Participants will also get an injection at
visit 3, 5 and 7. Participants will be trained to give all other injections themselves.
Participants must not use any clotting factors other than N8-GP or any anticoagulants (blood
thinners) during the study.


Inclusion Criteria:

- Male patients of all ages with the diagnosis of severe congenital haemophilia A
(coagulation Factor VIII [FVIII] activity less than 1%) based on medical records

- On-going participation in NN7088-3859 (pathfinder2), or NN7088-3885 (pathfinder5) at
the time of transfer

Exclusion Criteria:

- Known or suspected hypersensitivity to trial product including allergy to hamster
protein or related products

- Any disorder, except for conditions associated with haemophilia, which in the
investigator's opinion might jeopardise patient's safety or compliance with the
protocol - Current participation in any clinical trial (except NN7088-3859
(pathfinder2) or NN7088-3885 (pathfinder5)) of an approved or non-approved
investigational medicinal product
We found this trial at
19
sites
Baltimore, Maryland 21229
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Camperdown, New South Wales
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Camperdown,
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Charleston, South Carolina 29407
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Charleston, SC
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Charlotte, North Carolina 28277
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Charlotte, NC
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Cincinnati, Ohio 45229
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Cincinnati, OH
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Dayton, OH
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Detroit, Michigan 48201
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Detroit, MI
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Houston, Texas 77030
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Houston, TX
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Iowa City, Iowa 52242
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Iowa City, IA
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Lansing, Michigan 48911
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Lansing, MI
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Long Beach, California 90807
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Long Beach, CA
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Minneapolis, Minnesota 55404
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Minneapolis, MN
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Nashville, Tennessee 37203
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Nashville, TN
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New Hyde Park, New York 11042
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New Hyde Park, NY
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New Orleans, Louisiana 70112
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New Orleans, LA
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Norfolk, Virginia 23510
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Norfolk, VA
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Phoenix, Arizona 85053
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Phoenix, AZ
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Portland, Oregon 97239
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Portland, OR
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