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

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 31 days later Aug 1, 2031 → Sep 2031
See other at-risk trials from Arkansas Children's Hospital Research Institute

Record History

  1. Recruitment opened Lead sponsor: Arkansas Children's Hospital Research Institute to Arkansas Children's Hospital Research Institute · Primary endpoints: details revised at 1 of 1 entry · Primary completion pushed from Aug 1, 2031 to Sep 2031 · 6 more Show 9 more changesShow less
    • Lead sponsor: Arkansas Children's Hospital Research Institute to Arkansas Children's Hospital Research Institute
    • Primary endpoints: details revised at 1 of 1 entry
    • Primary completion pushed from Aug 1, 2031 to Sep 2031
    • Completion pushed from Aug 1, 2032 to Sep 2032
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 1, 2026 to Sep 21, 2026
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 2 of 4 entries
    • Publications: details revised at 13 of 13 entries
  2. Primary endpoint(s) modified Start date: Jun 1, 2026 to Jul 1, 2026 · Secondary endpoints expanded, about 35 words · Study description shortened, about 12 wordsv3 Show 3 more changesShow less
    • Start date: Jun 1, 2026 to Jul 1, 2026
    • Secondary endpoints expanded, about 35 words
    • Study description shortened, about 12 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study title shortened, about 1 wordv2 See this version in full on ClinicalTrials.gov ↗
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07582276
Lead Sponsor Arkansas Children's Hospital Research Institute
Collaborators: Genzyme, a Sanofi Company
Conditions Hemophilia a
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov