Adverse Event Data Collection From External Registries on Nonacog Beta Pegol

Novo Nordisk

Status: Invitation-only

Conditions: Haemophilia B

Treatments: Drug: Nonacog beta pegol

Study type: Observational

Funder types: Industry

Identifiers

NCT03690336

EUPAS25696 (Registry Identifier)

NN7999-4413

U1111-1212-4050 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Patients with haemophilia B

Description:

Patients with haemophilia B treated with nonacog beta pegol who report adverse events to the PedNet and EUHASS, and possibly other national or international registries.

Treatment:

Drug: Nonacog beta pegol