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 |
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.
(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
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