Congenital Bleeding Disorder, Haemophilia A
Conditions
Brief summary
Investigating single dose pharmacokinetics and safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process in patients with severe haemophilia A
Interventions
Administered as intravenous injections at a dose of 50 U/kg. Patients will receive each product in a randomised cross-over design for comparison of the pharmacokinetics between turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial * Ongoing participation in pathfinder™2 * Male, age at least 12 years at the time of signing informed consent (in certain countries the lower age limit will be 18 years, according to local requirements)
Exclusion criteria
* FVIII inhibitors (≥0.6 BU) at last visit in pathfinder™2 prior to entry in pathfinder™7 * Planned surgery during the trial * Major surgery performed within 4 weeks prior to screening * Previous participation in this trial. Participation is defined as signed informed consent * Any disorder, except for conditions associated with haemophilia A, which in the investigator's opinion might jeopardise patient's safety or compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the FVIII activity-time curve | From 0 to 96 hours post injection |
Secondary
| Measure | Time frame |
|---|---|
| FVIII activity 30 min post administration - dose normalised to 50 U/kg | From time of trial product administration to 96 hours post-dose |
| Area under the FVIII activity-time curve from 0 to infinity | From time of trial product administration to 96 hours post-dose |
| Clearance in blood plasma of FVIII activity | From time of trial product administration to 96 hours post-dose |
| Incremental recovery in blood plasma of FVIII activity | From time of trial product administration to 96 hours post-dose |
| Terminal half-life | From time of trial product administration to 96 hours post-dose |
Countries
Denmark, France, Germany, Netherlands, Spain, United States
Outcome results
None listed