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Goal Attainment and Physical Activity in People With Hemophilia A

TerminatedN/A

Sponsor: Sanofi

Conditions: Hemophilia A

Interventions: efanesoctocog alfa

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 12 Years to 50 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Locations (1)

Peoria, Illinois, United States