RecruitingNCT05621746

An Observational Research Study of the Health of Joints in People With Haemophilia Taking the Medicine Esperoct

Non-Interventional Study of the Change in Joint Health in Adult Patients With Haemophilia A After Switching to Prophylaxis With Turoctocog Alfa Pegol (N8-GP)


Sponsor

Novo Nordisk A/S

Enrollment

100 participants

Start Date

Nov 23, 2022

Study Type

OBSERVATIONAL

Conditions

Summary

This study will collect information on the long term health of joints in people with haemophilia A who have started treatment with Esperoct within twelve months prior to participation to the study. This study is conducted to look at how joint health of people with haemophilia changes over time when they are receiving the medicine Esperoct. The participants will get Esperoct as prescribed to the participants by the study doctor. The participant's treatment will not be affected by their involvement in the study. Every six months, the participants will be asked to answer some questionnaires about their joints, their pain and their ability to be physically active. Their participation in the study will last for no more than 2 years. The participants are free to leave the study at any time and for any reason. This will not affect their current and future medical care.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study is following men with moderate-to-severe haemophilia A who are switching to (or have recently switched to) Esperoct, a factor VIII replacement therapy used to prevent bleeding episodes. The study tracks joint health over time to see whether Esperoct helps preserve or improve joint function in patients with haemophilia. It does not involve any experimental treatments — patients simply continue their prescribed care while researchers collect health data. You may be eligible if: - You are male and 18 years of age or older - You have been diagnosed with severe (FVIII activity below 1%) or moderate (FVIII activity 1–5%) haemophilia A - You have recently switched or are about to switch to Esperoct for prophylactic (preventive) treatment - Your decision to use Esperoct was made independently from this study - You have baseline joint health data available from within 2 months before or 1 month after your switch You may NOT be eligible if: - You have previously participated in this study - You previously stopped Esperoct treatment - You were receiving Esperoct on-demand (not as regular prophylaxis) - You have a language barrier or cognitive impairment that prevents participation - You participated in a clinical trial within the 30 days before switching to Esperoct Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEsperoct

Participants will be treated with commercially available Esperoct for a total study duration of 24 months according to the local label and local routine clinical practice at the discretion of the physician. The decision to switch to Esperoct will be made prior to and separate from the decision to enrol in the study.


Locations(1)

Novo Nordisk Investigational Site

Hamilton, Ontario, Canada

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NCT05621746


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