Adverse Event Data Collection From External Registries on Nonacog Beta Pegol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-01

Study Completion Date

2027-10-01

Brief Summary

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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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Detailed Description

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Conditions

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Haemophilia B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Nonacog beta pegol

Intervention Type DRUG

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

Interventions

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Nonacog beta pegol

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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