Goal Attainment and Physical Activity in People With Hemophilia A
Stopped early
Conditions studied: Hemophilia A
In brief
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. This study aims to enroll 35 patients.
Key facts
- Study ID
- NCT06530030
- Run by
- Sanofi
- People needed
- 3
- Starts
- 2024-11-26
- Expected to finish
- 2025-09-18
- Last updated by the study team
- 2026-01-20
Who can join
Age: 12 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Bleeding and Clotting Disorders Institute — Peoria, Illinois, United States
Full record on ClinicalTrials.gov
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