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

NCT05621746 | Recruiting DMC

• 2 other identifiers: NN7088-4928U1111-1271-9209
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in haemophilia joint health score (HJHS)

  Measured as units on a score. The scoring range of the HJHS is from 0 (normal, healthy joints) to 124 (maximum severity). A sustained HJHS is defined as a change in total score of less than or equal to (\<=) 2 points over 24 months.

  From date of switch to end of study (up to 24 months)

Secondary Outcomes (6)

• The number of bleeding episodes requiring coagulation Factor VIII (FVIII) treatment

  From baseline to end of study (up to 24 months)

• Number of target joints

  From baseline to end of study (up to 24 months)

• Resolution of any target joints (Yes/No)

  From baseline to end of study (up to 24 months)

• Change in patient reported Problem Joint score

  From baseline to end of study (up to 24 months)

• Change in patient reported pain scores (Brief Pain Inventory)

  From baseline to end of study (up to 24 months)

Study Arms (1)

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.

Drug: Esperoct

Interventions

Esperoct 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.

Also known as: Turoctocog alfa pegol (N8-GP)

Participants with Haemophilia A

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with Haemophilia A

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Hamilton, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Clinical Transparency' dept. 2834

  Novo Nordisk A/S'

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 18, 2022
• Study Start: November 23, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)