Goal Attainment and Physical Activity in People With Hemophilia A (ACTIVIIITY)

Sanofi

Status: Terminated

Conditions: Hemophilia A

Treatments: Drug: efanesoctocog alfa

Study type: Observational

Funder types: Industry

Identifiers

NCT06530030

OBS18140

U1111-1306-7241 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 12 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

3 participants in 1 patient group

Cohort

Description:

patients aged 12 to 50 years with moderate or severe hemophilia A who are newly starting prophylaxis with efa

Treatment:

Drug: efanesoctocog alfa