Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A



Status:Completed
Conditions:Hematology, Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:2/1/2019
Start Date:October 10, 2016
End Date:June 20, 2017

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A Multicentre, Open-label Trial Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics
(the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to
BMI (body mass index) in subjects with haemophilia A.


Inclusion Criteria:

- Male, age at least 18 years at the time of signing informed consent

- History of more than 150 exposure days to any factor VIII products

- Subjects with the diagnosis of congenital haemophilia A with factor VIII activity
below 1%, based on medical records

Exclusion Criteria:

- Known history of factor VIII inhibitors

- Inhibitors to factor VIII (above or equal to 0.6 BU (Bethesda units)) at screening
measured by the Nijmegen modified Bethesda method

- Known congenital or acquired coagulation disorders other than haemophilia A

- Previous participation in pharmacokinetic sessions with turoctocog alfa in another
trial
We found this trial at
5
sites
Richmond, Virginia 23219
2267
mi
from 91732
Richmond, VA
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Chicago, Illinois 60612
1728
mi
from 91732
Chicago, IL
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Memphis, Tennessee 38119
1598
mi
from 91732
Memphis, TN
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Peoria, Illinois 61615
1618
mi
from 91732
Peoria, IL
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6093
mi
from 91732
Wien,
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