Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
Conditions
Brief summary
This study is conducted in Europe and Asia. The aim of this observational study is to monitor antibody formation towards the room temperature stable formulation of NovoSeven® (activated recombinant human factor VII).
Interventions
DRUGactivated recombinant human factor VII
Administration of room temperature stable NovoSeven® (activated recombinant human factor VII) in dosages prescribed by the treating physician according to the product labelling text approved in his country.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Diagnosed with congenital haemophilia A or B with inhibitors to factor VIII or factor IX * Treated with room temperature stable NovoSeven®
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduced therapeutic response and neutralising antibodies to activated recombinant human factor VII as confirmed by central laboratory | after 25 exposure days |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events reported as potentially related to activated recombinant human factor VII | after 25 exposure days |
Countries
Argentina, Austria, Belgium, France, Germany, Hungary, Iran, Ireland, Italy, Poland, Portugal, Slovakia, Sweden, United Kingdom
Outcome results
None listed