Adverse Event Data Collection From External Registries on Nonacog Beta Pegol

Condition(s) studied

Investigational drug(s) / intervention(s)

Nonacog beta pegol: Treatment with commercially available nonacog beta pegol according to routine clinical practice at the discretion of the treating physician.

Study 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.

Eligibility

Primary outcome measure(s)

• 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)

Trial sites (2)

More Novo Nordisk A/S trials in the Netherlands