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NCT03690336 Clinical Trial

Adverse Event Data Collection From External Registries on Nonacog Beta Pegol

Haemophilia B Clinical Trial

Official title:
Adverse Event Data Collection From External Registries on Nonacog Beta Pegol

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03690336
Other study ID # NN7999-4413
Secondary ID U1111-1212-4050E
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 1, 2018
Est. completion date October 1, 2027

Study information
Verified date February 2024
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 10
Est. completion date October 1, 2027
Est. primary completion date October 1, 2027
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Netherlands Novo Nordisk Investigational Site Baarn
United Kingdom Novo Nordisk Investigational Site Sheffield

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Netherlands,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Other ADRs reported to the registries during the study period with suspected relation to nonacog beta pegol in patients with haemophilia B 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)
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