Haemophilia B
Conditions
Brief summary
The purpose of this study is to collect data on adverse events from third party registries that include information about adverse events from patients with haemophilia B treated with nonacog beta pegol. The third party registries include PedNet Haemophilia Registry (PedNet) and the European Haemophilia Safety Surveillance System (EUHASS). Data from national and international registries in countries where nonacog beta pegol has been approved and marketed could be included in the data collection.
Interventions
Treatment with commercially available nonacog beta pegol according to routine clinical practice at the discretion of the treating physician.
Sponsors
Novo Nordisk A/S
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- Participation in the PedNet Registry and/or the European Haemophilia Safety Surveillance System (EUHASS), or other national and international registries
Exclusion criteria
\- Not applicable as this is a study collecting third-party data from registries
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Drug Reactions (ADRs) reported to the registries with suspected relation to nonacog beta pegol in patients with haemophilia B | From start of data collection (week 0) to end of data collection (after 9 years) | Number of events (renal, hepatic, neurodevelopmental, neurocognitive, neurologic or psychiatric events) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Other ADRs reported to the registries during the study period with suspected relation to nonacog beta pegol in patients with haemophilia B | From start of data collection (week 0) to end of data collection (after 9 years) | Number of events (de novo FIX inhibitors more than or equal to 0.6 Bethesda units); anaphylaxis and other allergic reactions; thromboembolic events) |
Countries
Netherlands, United Kingdom
Outcome results
None listed