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

Last updated: May 30, 2025
Sponsor: Novo Nordisk A/S
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hemophilia

Treatment

Esperoct

Clinical Study ID

NCT05621746
NN7088-4928
U1111-1271-9209
  • Ages > 18
  • Male

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Signed consent obtained before any study-related activities (study-relatedactivities are any procedure related to recording of data according to theprotocol).

  • Male, greater than or equal to 18 years of age at the time of signing informedconsent, diagnosed with severe (FVIII activity below 1%) or moderate congenitalhaemophilia A (FVIII activity 1-5%).

  • The decision to initiate treatment with commercially available Esperoct has beenmade by the patient and the treating physician before and independently from thedecision to include the patient in this study.

  • Switched, within two months prior to enrolment, OR planned to switch, within onemonth post enrolment, to prophylaxis treatment with Esperoct from previous therapy;the decision to initiate treatment with Esperoct must be made prior to andindependently from the decision to enrol in the study.

  • Must have baseline data (HJHS, target joints, and medical history) collected inroutine clinical practice within two months prior or up to one month post switch toEsperoct therapy.

Exclusion

Exclusion Criteria:

  • Previous participation in this study. Participation is defined as having giveninformed consent in this study.

  • Previous terminated treatment regimen with Esperoct prophylaxis.

  • Current or previously terminated treatment regimen with Esperoct on-demand.

  • Mental incapacity, unwillingness or language barriers precluding adequateunderstanding or cooperation.

  • Previous participation in a clinical trial within the 30 days prior to switching toEsperoct.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Esperoct
Phase:
Study Start date:
November 23, 2022
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Novo Nordisk Investigational Site

    Hamilton, Ontario
    Canada

    Active - Recruiting

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