Congenital Bleeding Disorder, Haemophilia A
Conditions
Brief summary
This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.
Interventions
DRUGturoctocog alfa
Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 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 * Male subjects with the diagnosis of severe haemophilia A (FVIII\<1%) from age 18 years * Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds) * Immunocompetent (HIV (Human Immunodeficiency Virus) positive subjects should have CD4+ (Cluster of differentiation 4; a glycoprotein expressed on the surface) lymphocyte count \>200/microL)
Exclusion criteria
* Detectable inhibitors to FVIII (above or equal to 0.6 Bethesda Units (BU)) * History of FVIII inhibitors * Severe current hepatic dysfunction or severe hepatic disease during the last 12 months * Known or suspected allergy to trial product (FVIII) or related products * Subjects receiving immune modulating medication or immune tolerance induction (ITI) regimens * Body mass index (BMI) above 30 kg/m\^2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay | up to 48 hours after i.v. administration |
Secondary
| Measure | Time frame |
|---|---|
| Incremental recovery (IR30min) (defined as the peak FVIII level recorded 30 min after injection and reported as[IU/mL]/[IU/kg]) | up to 48 hours after i.v. administration |
| Area under the FVIII activity-time curve (AUC) | up to 48 hours after i.v. administration |
| Dose normalised area under the FVIII activity-time curve (AUC/actual dose) based on one stage clot assay | up to 48 hours after i.v. administration |
| Clearance of FVIII (CL) | up to 48 hours after i.v. administration |
| Incidence of adverse events (AEs) including FVIII inhibitors | After approximately 3 months (at end of trial) |
| Terminal half-life of FVIII (t½) | up to 48 hours after i.v. administration |
Countries
Germany, Latvia, Malaysia, Spain
Outcome results
None listed