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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04682145
Recruitment Status : Enrolling by invitation
First Posted : December 23, 2020
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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 alfapegol. There is no extra burden to the patients by participating in this registry-based data collection.

Condition or disease Intervention/treatment
Haemophilia A Drug: Turoctocog alfa pegol

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Adverse Event Data Collection From the EUHASS Registry on Turoctocog Alfa Pegol
Actual Study Start Date : December 9, 2020
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

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.




Primary Outcome Measures :
  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. [ Time Frame: From start to end of data collection (December 2019 to January 2025) ]
    Count


Secondary Outcome Measures :
  1. 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).



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04682145


Locations
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Denmark
Novo Nordisk Investigational Site
Søborg, Denmark, 2860
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor & Disclosure (1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04682145    
Other Study ID Numbers: NN7088-4557
U1111-1235-5939 ( Other Identifier: World Health Organization (WHO) )
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn