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

Haemophilia A Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04682145
• Other study ID #: NN7088-4557
• Secondary ID: U1111-1235-5939
• Status: Enrolling by invitation
• Start date: December 9, 2020
• Est. completion date: April 1, 2025

Study information

• Verified date: February 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Haemophilia A
• Hemophilia A

Intervention

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.

Locations

Country	Name	City	State
Denmark	Novo Nordisk Investigational Site	Søborg

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Count	From start to end of data collection (December 2019 to January 2025)
Secondary	Other AEs reported to the registry during the study period with suspected relation to turoctocog alfa pegol in patients with haemophilia A	Count. Includes ADRs of special interest (de novo FVIII inhibitors equal to or above 0.6 Bethesda Units (BU)); anaphylaxis and other allergic reactions; thromboembolic events).	From start to end of data collection (December 2019 to January 2025)