Goal Attainment and Physical Activity in People With Hemophilia A

Description

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.

Conditions

Hemophilia A

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Study Overview

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Study Details

Study overview

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.

Prospective, Observational Study of the Impact of Efanesoctocog Alfa (ALTUVIIIO®) on Goal Attainment and Physical Activity in People With Moderate or Severe Hemophilia A

Goal Attainment and Physical Activity in People With Hemophilia A

Condition
Hemophilia A
Intervention / Treatment

-

Contacts and Locations

Peoria

Bleeding and Clotting Disorders Institute, Peoria, Illinois, United States, 61614

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

12 Years to 50 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sanofi,

Study Record Dates

2026-08-31