Enrolling by invitation NCT04682145

Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol

— Observational Haemophilia A

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: Turoctocog alfa pegol.
Who it may be relevant to: Registry conditions: Haemophilia A. 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: Denmark
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

This non-interventional study concerns a safety data collection based on adverse event data from a third-party registry (European Haemophilia Safety Surveillance System, EUHASS) that includes information about adverse events from patients with haemophilia A treated with turoctocog alfa pegol. There is no extra burden to the patients by participating in this registry-based data collection.

Interventions

Drug Turoctocog alfa pegol
Patients will be treated with commercially available turoctocog alfa pegol according to routine clinical practice at the discretion of the treating physician. A decision to initiate treatment with commercially available turoctocog alfa pegol has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in the registry in scope.

Primary outcome measures

Adverse events (AEs) reported to the registry with suspected relation to turoctocog alfa pegol, Adverse Drug Reactions (ADRs), in patients with haemophilia A for renal, hepatic and neurological events. [Time frame: From start to end of data collection (December 2019 to January 2025)]

Secondary outcome measures (1)

Other AEs reported to the registry during the study period with suspected relation to turoctocog alfa pegol in patients with haemophilia A [Time frame: From start to end of data collection (December 2019 to January 2025)]

Eligibility criteria

Inclusion criteria

Participation in the European Haemophilia Safety Surveillance System (EUHASS).

Exclusion criteria

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

Denmark · 1 center

Novo Nordisk Investigational Site — Søborg

Identifiers

NCT: NCT04682145 · NN7088-4557 · U1111-1235-5939

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗