Observing joint health in people with haemophilia A taking 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)
This study looks at how joint health changes over time in people with haemophilia A who are starting treatment with Esperoct.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT05621746 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect data on the long-term health of joints in individuals with haemophilia A who have recently started treatment with Esperoct. Participants will complete questionnaires every six months regarding their joint health, pain levels, and physical activity capabilities over a period of up to two years. The study does not alter the participants' prescribed treatment and allows them to withdraw at any time without affecting their medical care. The goal is to understand how joint health evolves in patients receiving Esperoct.
Who should consider this trial
Good fit: Ideal candidates are adult males diagnosed with severe or moderate congenital haemophilia A who have recently initiated treatment with Esperoct.
Not a fit: Patients who are not male, under 18 years old, or who have not switched to Esperoct treatment within the specified time frame may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the management of joint health in patients with haemophilia A, potentially leading to improved treatment strategies.
How similar studies have performed: While this approach is observational, similar studies have successfully provided insights into treatment outcomes in patients with haemophilia.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hamilton, Ontario
- Novo Nordisk Investigational Site — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.