Adverse Event Data Collection From External Registries on Nonacog Beta Pegol

NCT03690336 | Enrolling By Invitation

• 3 other identifiers: NN7999-4413U1111-1212-4050EUPAS25696
• Study Type: observational
• Target: 10
• Locations: 2 countries
• Sites: 2

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.

Conditions

Haemophilia B

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (1)

• 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)

Study Arms (1)

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

Interventions

Nonacog beta pegol DRUG

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

Patients with haemophilia B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with haemophilia B

You may qualify if:

• \- Participation in the PedNet Registry and/or the European Haemophilia Safety Surveillance System (EUHASS), or other national and international registries

You may not qualify if:

• \- Not applicable as this is a study collecting third-party data from registries

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

PedNet Haemophilia Registry

Baarn, Netherlands

Location

European Haemophilia Safety Surveillance Registry

Sheffield, United Kingdom

Location

MeSH Terms

Conditions

Hemophilia B

Interventions

nonacog beta pegol

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Transparency (2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: October 1, 2018
• Study Start: October 1, 2018
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: June 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); NL (1)