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

September 24, 2025 updated by: Novo Nordisk A/S
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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Søborg, Denmark, 2860
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with haemophilia A treated with turoctocog alfa pegol and reporting adverse events to EUHASS.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Haemophilia A patients
All patients with haemophilia A treated with turoctocog alfa pegol and reporting adverse events to EUHASS.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Count
From start to end of data collection (December 2019 to January 2025)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Reporting Anchor & Disclosure (2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2020

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 22, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN7088-4557
  • U1111-1235-5939 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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