Adverse Event Data Collection From External Registries on Nonacog Beta Pegol
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nonacog beta pegol.
- Who it may be relevant to
- Registry conditions: Haemophilia B. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Nonacog beta pegol
Treatment with commercially available nonacog beta pegol according to routine clinical practice at the discretion of the treating physician.
Primary outcome measures
- 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)]
Secondary outcome measures (1)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 1 center
- PedNet Haemophilia Registry — Baarn
United Kingdom · 1 center
- European Haemophilia Safety Surveillance Registry — Sheffield
Identifiers
NCT: NCT03690336 · NN7999-4413 · U1111-1212-4050 · EUPAS25696