A Trial Comparing Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
| Status: | Completed |
|---|---|
| Conditions: | Hematology, Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/22/2018 |
| Start Date: | March 7, 2017 |
| End Date: | December 8, 2017 |
A Trial Comparing the Pharmacokinetics of Nonacog Beta Pegol (N9-GP) and ALPROLIX® in Patients With Haemophilia B
This trial is conducted in Europe and the United States of America. The aim of this trial is
to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta
pegol (N9-GP) and ALPROLIX® in patients with haemophilia B.
to compare the pharmacokinetics (the exposure of the trial drug in the body) of nonacog beta
pegol (N9-GP) and ALPROLIX® in patients with haemophilia B.
Inclusion Criteria:
- Male, aged 18-70 years (both inclusive) at the time of signing informed consent
- Patients with the diagnosis of congenital haemophilia B with factor IX activity below
or equal to 2%, based on medical records
- History of more than 150 exposures days to any factor IX containing products
Exclusion Criteria:
- Known history of factor IX inhibitors
- Inhibitors to factor IX (above or equal to 0.6 BU) at screening measured by the
Nijmegen modified Bethesda method
- Immunocompromised (CD4+ T cells below or equal to 200/μL)
- Known congenital or acquired coagulation disorders other than haemophilia B
- Body mass index above 35 kg/m^²
We found this trial at
8
sites
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