Adverse Event Data Collection From External Registries on Nonacog Beta Pegol

• Conditions: Haemophilia B
• Interventions: Drug: Nonacog beta pegol

• Registration Number: NCT03690336
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-21
• Study Start: 2018-10-01
• Study First Posted: 2018-10-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 10

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with haemophilia B	Nonacog beta pegol	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.

Primary Outcome Measures

Name	Time	Method
Adverse Drug Reactions (ADRs) reported to the registries 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)	Number of events (renal, hepatic, neurodevelopmental, neurocognitive, neurologic or psychiatric events)

Secondary Outcome Measures

Name	Time	Method
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)	Number of events (de novo FIX inhibitors more than or equal to 0.6 Bethesda units); anaphylaxis and other allergic reactions; thromboembolic events)

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Sheffield, United Kingdom