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

Launched by NOVO NORDISK A/S · Nov 10, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the long-term health of joints in men with Haemophilia A who have recently started treatment with a medicine called Esperoct. The researchers want to understand how joint health changes over time for these patients. To participate, men must be at least 18 years old, have a diagnosis of moderate to severe Haemophilia A, and have recently switched to Esperoct treatment. It's important that the decision to use Esperoct was made by the patient and their doctor before they joined the study.

Participants in this study will continue taking Esperoct as prescribed by their doctor and will not be affected by their involvement. Every six months, they will complete questionnaires about their joint health, pain levels, and physical activity. The study will last no longer than two years, and participants can leave at any time without it affecting their medical care. This study aims to help improve understanding of joint health in people with Haemophilia A receiving Esperoct, which could lead to better care in the future.

Gender

MALE

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.