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

NCT04682145 | Enrolling By Invitation

• 2 other identifiers: NN7088-4557U1111-1235-5939
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Haemophilia A

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Other AEs reported to the registry during the study period with suspected relation to turoctocog alfa pegol in patients with haemophilia A

  From start to end of data collection (December 2019 to January 2025)

Study Arms (1)

Haemophilia A patients

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

Drug: Turoctocog alfa pegol

Interventions

Turoctocog alfa pegol DRUG

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.

Haemophilia A patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Søborg, 2860, Denmark

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Clinical Reporting Anchor & Disclosure (2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 23, 2020
• Study Start: December 9, 2020
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)