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Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy

Study acronym: SYNOVIIIUS
StatusRecruiting
PhasePhase 4
SponsorSanofi
Started
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Record History

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  1. Minor Study sites: 13 to 14
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: details revised at 6 of 18 entries
  2. Minor Study sites: 12 to 13v3
  3. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Mar 16, 2027 to Oct 25, 2027
    • Start date changed from estimate of May 30, 2025 to Sep 23, 2025
    • Study sites: 0 to 12
    • Study completion date: Jun 15, 2027 to Oct 25, 2027
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
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241 trials monitored
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The objective of the study is to assess the improvement of synovial hypertrophy during the 12 months of efanesoctocog alfa prophylaxis once per week (QW) in joints with existing evidence of synovial hypertrophy in participants with hemophilia A. The study duration for each participant is approximately 12 months.
Trial Details
NCT Number NCT06941870
Lead Sponsor Sanofi
Conditions
(from sponsor)
Factor VIII Deficiency
Related terms Hemophilia A
Enrollment 35 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov