Congenital Bleeding Disorder, Haemophilia A
Conditions
Brief summary
This trial is conducted globally. 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 NNC 0129-0000-1003 in previously treated subjects with severe haemophilia A.
Interventions
Single dose (low) 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
* Haemophilia A * Body Mass Index (BMI) below 35 kg/m2 * History of a minimum 150 exposure days (EDs) to FVIII products (prophylaxis/prevention/surgery/on-demand)
Exclusion criteria
* Any history of FVIII inhibitors * Surgery planned to occur during the trial * Platelet count less than 50,000 platelets/microlitre (assessed by laboratory) * Congenital or acquired coagulation disorders other than haemophilia A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of adverse events (AEs) reported after administration of trial product | up to four weeks after trial product administration |
Secondary
| Measure | Time frame |
|---|---|
| Area under the curve (AUC), total clearance (CL), terminal half-life (T½), incremental recovery (first sample) | from 0 to 168 hours after trial product administration |
| Safety assessment including physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory assessments | up to four weeks after trial product administration |
Countries
Germany, Italy, Japan, Switzerland, Turkey (Türkiye), United Kingdom, United States
Outcome results
None listed