A Prospective Assessment of Bone Health in Patients With Severe Hemophilia A on Factor VIII vs Factor Mimetic Prophylaxis (Efa Emi Bone Health Study)

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Arkansas Children's Hospital Research Institute
Study ID
NCT07582276
Status
Recruiting
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Conditions

  • Hemophilia a

Eligibility Criteria

Sex
MALE
Age
30 Years - 50 Years
Healthy Volunteers
Not accepted

Study Details

This study will compare bone mineral density in patients with severe hemophilia A receiving prophylaxis with emicizumab or efanesoctocog alfa. Participants will undergo assessments of bone mineral density, bone remodeling biomarkers, thrombin generation, plasmin generation, and joint health over a five-year period. The study aims to evaluate whether differences in prophylactic therapy are associated with differences in bone health outcomes.

Key Dates

First listed
May 12, 2026
Start date
Sep 21, 2026
Status verified
Oct 2026
Primary completion
Sep 30, 2031
Completion
Sep 30, 2032

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Patients with Severe Hemophilia A on Efanesoctocog alfa prophylaxis
    Participants with severe hemophilia A receiving prophylaxis with efanesoctocog alfa as part of routine clinical care. Participants will undergo longitudinal assessments of bone mineral density, bone remodeling biomarkers, thrombin generation, plasmin generation, and joint health over a five-year period.
  • Arm: Patients with Severe Hemophilia A on Emicizumab prophylaxis
    Participants with severe hemophilia A receiving prophylaxis with emicizumab as part of routine clinical care. Participants will undergo longitudinal assessments of bone mineral density, bone remodeling biomarkers, thrombin generation, plasmin generation, and joint health over a five-year period.

Primary Outcome Measure

Longitudinal change in femoral neck bone mineral density (g/cm²) [ Time Frame: Baseline and annually through 5 years. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Arkansas Children'sLittle RockArkansas72202-

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By research site
Arkansas Children's· Little Rock, AR

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