A Study to Evaluate Impact of Efanesoctocog Alfa on Long-term Joint Health in Participants With Hemophilia A

Launched by SANOFI · Jun 19, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the long-term effects of a treatment called efanesoctocog alfa for people with hemophilia A, a condition that affects the blood's ability to clot. The goal is to understand how well this treatment works, its safety, and how it is used in real-life settings in the United States and Japan. Patients will be monitored during their regular doctor visits for up to five years after they start this treatment.

To participate in the study, patients must have hemophilia A and begin treatment with efanesoctocog alfa within a month of joining the trial. They should not have any other bleeding disorders or be part of another clinical trial at the same time. Participants will not receive any study medication; instead, the study focuses on collecting information about their experiences with the treatment during routine check-ups. It's important to know that the decision to use efanesoctocog alfa is made by the doctor before enrolling in the study, ensuring that patient care remains the priority.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Have a diagnosis of hemophilia A
• • Patients starting efanesoctocog alfa treatment as per standard of care no more than one month prior to the enrollment date, for either on demand or prophylaxis. Patients starting efanesoctocog alfa treatment for a surgery event may also be enrolled only if the treatment is prescribed at enrollment.
• • Physician's decision to treat the patient with efanesoctocog alfa is made prior to and independently of participation in the study.
• • Signed and dated informed consent provided by the patient, or by the patient's legally acceptable representative for patients under the legal age before any study-related activities are undertaken. Assent should be obtained for pediatric patients according to local regulations.
• Exclusion Criteria:
• • Diagnosed with other known bleeding disorder
• • Participation in an investigational medicinal product trial at enrollment visit, or intake of an Investigational Medicinal Product within 3 months prior to inclusion in this study
• • Current diagnosis of a FVIII inhibitor, defined as inhibitor titer ≥0.60 BU/mL
• • "The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial."