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

NCT ID: NCT04682145

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-09

Study Completion Date

2026-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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Haemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Haemophilia A patients

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

Turoctocog alfa pegol

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* N/A
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor & Disclosure (2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Søborg, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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U1111-1235-5939

Identifier Type: OTHER

Identifier Source: secondary_id

NN7088-4557

Identifier Type: -

Identifier Source: org_study_id

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