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NCT06530030Terminated

Goal Attainment and Physical Activity in People With Hemophilia A

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

Source: ClinicalTrials.gov · Last updated 20 Jan 2026

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Study type
Observational
Enrollment
3 (actual)
First submitted
17 Jul 2024
Start date
26 Nov 2024
Primary completion date
18 Sept 2025
Lead sponsor
Sanofi
Diseases
Haemophilia
NCT number
NCT06530030

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Who the study is looking for

  • 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

Age in the registry: 12 years to 50 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Bleeding and Clotting Disorders Institute
Coordinator of this site? Confirm its status
PeoriaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.