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

NCT ID: NCT05621746

Last Updated: 2025-06-02

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-23
• Study Completion Date: 2026-06-30

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 Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Esperoct

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

Turoctocog alfa pegol (N8-GP)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency' dept. 2834

Role: STUDY_DIRECTOR

Novo Nordisk A/S'

Locations

Novo Nordisk Investigational Site

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Novo Nordisk

Role: CONTACT

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Other Identifiers

U1111-1271-9209

Identifier Type: OTHER

Identifier Source: secondary_id

NN7088-4928

Identifier Type: -

Identifier Source: org_study_id