Status:
RECRUITING
Goal Attainment and Physical Activity in People With Hemophilia A
Lead Sponsor:
Sanofi
Conditions:
Hemophilia A
Eligibility:
All Genders
12-50 years
Brief Summary
This is a Phase 4, multi-center, observational study conducted in patients aged 12 to 50 years with moderate or severe hemophilia A who are newly starting prophylaxis with efa in the US and Japan. Th...
Eligibility Criteria
Inclusion
- At enrollment, newly starting prophylaxis therapy with efanesoctocog alfa according to usual clinical practice, with efanesoctocog alfa initiated within 6 months after the enrollment visit
- Diagnosis of moderate (endogenous FVIII activity between 1% to 5% of normal) or severe (endogenous FVIII activity \<1% of normal) hemophilia A
- Aged 12 to 50 years at time of enrollment, inclusive
- Access to a smartphone device (Android version 12.0 or higher; or iOS 13 or higher) with Bluetooth 4.0 (minimum) or 5.0 (recommended) capabilities for compatibility with physical activity tracker
- Availability of home-based access to internet for electronic patient-reported outcome (ePRO)/diary assessments
- Willingness to utilize the activity tracking device
Exclusion
- Current diagnosis of a FVIII inhibitor, defined as inhibitor titer ≥ 0.60 BU/mL
- Use of efanesoctocog alfa for prophylaxis in the 6 months prior to enrollment
- NOTE: Other Inclusion/Exclusion criteria may apply. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Key Trial Info
Start Date :
November 26 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06530030
Start Date
November 26 2024
End Date
August 31 2026
Last Update
February 3 2025
Active Locations (1)
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1
Bleeding and Clotting Disorders Institute
Peoria, Illinois, United States, 61614