Goal Attainment and Physical Activity in People With Hemophilia A

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-26

Study Completion Date

2025-09-18

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

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

efanesoctocog alfa

Intervention Type DRUG

All treatment decisions must be made independent of study participation and study-related visits/assessments are not intended to inform treatment decisions. No study medication is provided as part of study participation.

Interventions

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efanesoctocog alfa

All treatment decisions must be made independent of study participation and study-related visits/assessments are not intended to inform treatment decisions. No study medication is provided as part of study participation.

Intervention Type DRUG

Other Intervention Names

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Altuviiio

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No