Congenital Bleeding Disorder, Haemophilia B
Conditions
Brief summary
This trial is conducted in Europe, Japan and the United States of America (USA). The aim of this clinical trial is to investigate the safety and pharmacokinetics (the determination of the concentration of the administered medication in blood over time) of Pegylated Recombinant Factor IX (nonacog beta pegol) in Non-Bleeding Patients with Haemophilia B.
Interventions
Cohort to receive a single dose of 25U/kg nonacog beta pegol administered intravenously (into the vein)
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with haemophilia B (baseline level of Factor IX less than or equal to 2%) * History of at least 150 exposure days to any Factor IX products * Body Mass Index (BMI) below 30.0 kg/m2 (inclusive)
Exclusion criteria
* History of Factor IX inhibitors * Platelet count less than 50,000 platelets/microlitre (assessed by laboratory) * Kidney or liver dysfunction * Scheduled surgery requiring Factor IX replacement therapy, during the trial period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of Adverse Events (AEs), Serious Adverse Events (SAEs) and Medical Events of Special Interests (MESIs) reported during the trial period | assessed up to five weeks after trial product administration |
| Antibody formation against 40K PEG-rFIX and test for inhibitors (Bethesda) | assessed up to five weeks after trial product administration |
Secondary
| Measure | Time frame |
|---|---|
| AUC, CL, T½, Incremental recovery (first sample) from 0 to 48 hours after trial product administration | assessed up to five weeks after trial product administration |
| AUC, CL, T½, Incremental recovery (first sample) from 0 to 168 hours after trial product administration | assessed up to five weeks after trial product administration |
Countries
Denmark, France, Germany, Japan, Spain, Sweden, United Kingdom, United States
Outcome results
None listed