Adverse Event Data Collection From External Registries on Nonacog Beta Pegol

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.

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Key information

Conditions

Haemophilia B Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia B Hemorrhagic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

PedNet Haemophilia Registry, Baarn, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nonacog beta pegol

Drug

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

Primary outcomes

Adverse Drug Reactions (ADRs) reported to the registries with suspected relation to nonacog beta pegol in patients with haemophilia B

Time frame: 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 outcomes

Other ADRs reported to the registries during the study period with suspected relation to nonacog beta pegol in patients with haemophilia B

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start: 2018
Primary completion: 2027
Study completion: 2027
First posted: Oct 1, 2018
Registry last updated: Jun 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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