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

Use our guide to learn which trials are right for you!

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
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Baltimore, Maryland 21229
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Camperdown, New South Wales
?
mi
from
Camperdown,
Click here to add this to my saved trials
Charleston, South Carolina 29407
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28277
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
Detroit, Michigan 48201
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Iowa City, Iowa 52242
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Lansing, Michigan 48911
?
mi
from
Lansing, MI
Click here to add this to my saved trials
Long Beach, California 90807
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Minneapolis, Minnesota 55404
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Hyde Park, New York 11042
?
mi
from
New Hyde Park, NY
Click here to add this to my saved trials
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Norfolk, Virginia 23510
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85053
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Portland, Oregon 97239
?
mi
from
Portland, OR
Click here to add this to my saved trials