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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• 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. — From start to end of data collection (December 2019 to January 2025)
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Trial sites (1)

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