Recruiting

Esperoct with Medicine

Sponsor:

Novo Nordisk A/S

Code:

NCT05621746

Conditions

Haemophilia A

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Esperoct

Study Details

Brief 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.

Conditions

Haemophilia A

Study ID

NCT05621746

Start date

Nov 23, 2022

Status verified date

May, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
  • Male, greater than or equal to 18 years of age at the time of signing informed consent, diagnosed with severe (FVIII activity below 1%) or moderate congenital haemophilia A (FVIII activity 1-5%).
  • The decision to initiate treatment with commercially available Esperoct has been made by the patient and the treating physician before and independently from the decision to include the patient in this study.
  • Switched, within two months prior to enrolment, OR planned to switch, within one month post enrolment, to prophylaxis treatment with Esperoct from previous therapy; the decision to initiate treatment with Esperoct must be made prior to and independently from the decision to enrol in the study.
  • Must have baseline data (HJHS, target joints, and medical history) collected in routine clinical practice within two months prior or up to one month post switch to Esperoct therapy.

Exclusion Criteria:

  • Previous participation in this study. Participation is defined as having given informed 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 adequate understanding or cooperation.
  • Previous participation in a clinical trial within the 30 days prior to switching to Esperoct.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Participants with Haemophilia A

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.

Interventions

Esperoct

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.

Primary outcome measure

  • Change in haemophilia joint health score (HJHS) [ Time Frame: From date of switch to end of study (up to 24 months) ]

Central Contacts and Locations

Central contacts

Novo Nordisk

(+1) 866-867-7178clinicaltrials@novonordisk.com

Locations

Novo Nordisk Investigational Site

Recruiting

Hamilton, Ontario, Canada

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Jun 2, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2025-06-02.