Adverse Event Data Collection From External Registries on Nonacog Beta Pegol

May 30, 2025 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Baarn, Netherlands
        • PedNet Haemophilia Registry
  • United Kingdom
      • Sheffield, United Kingdom
        • European Haemophilia Safety Surveillance Registry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with haemophilia B

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with haemophilia B
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.
Drug: Nonacog beta pegol
Treatment with commercially available nonacog beta pegol according to routine clinical practice at the discretion of the treating physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From start of data collection (week 0) to end of data collection (after 9 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
From start of data collection (week 0) to end of data collection (after 9 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

September 21, 2018

First Submitted That Met QC Criteria

September 21, 2018

First Posted (Actual)

October 1, 2018

Study Record Updates

Last Update Posted (Actual)

June 2, 2025

Last Update Submitted That Met QC Criteria

May 30, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7999-4413
  • U1111-1212-4050 (Other Identifier: World Health Organization (WHO))
  • EUPAS25696 (Registry Identifier: EU PAS Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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