Congenital Bleeding Disorder, Haemophilia A With Inhibitors, Haemophilia B With Inhibitors
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to evaluate the efficacy and safety of two dose schedules of activated recombinant human factor VII in treatment of joint bleeds in haemophilia patients with inhibitors.
Interventions
DRUGactivated recombinant human factor VII
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Diagnosed of congenital haemophilia A or B with inhibitors to factor VIII or IX, respectively * A history of 3 or more joint bleeds during the last 12 months
Exclusion criteria
* Joint bleeding within 7 days prior to trial start * Treatment for bleeds within the last 5 days prior to trial start * Clinically relevant coagulation disorders other than congenital haemophilia A or B
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global treatment response of the patient by an algorithm based pain and joint mobility assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain assessment | — |
| Mobility assessment | — |
| Circumference of joint | — |
| Adverse events | — |
Countries
France, Hungary, Israel, Poland, Spain, Turkey (Türkiye), United Kingdom
Outcome results
None listed