Clinical Trial

A Study to Investigate the Course of Synovial Hypertrophy in Patients With Haemophilia A on Efanesoctocog Alfa Prophylaxis

Active, Not Recruiting Phase 4
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Summary
The rationale for conducting this open-label phase 4 study is to assess whether once-weekly prophylaxis with efanesoctocog alfa (50 IU/kg) improves the disease course of existing synovial hypertrophy and prevents the risk of joint bleeds in patients with moderate or severe haemophilia A. The use of imaging assessments will allow for objective detection and monitoring of synovial hypertrophy, and thus expand on the previous findings demonstrating positive effects of once-weekly prophylaxis with efanesoctocog alfa (50 IU/kg) on joint health.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2024-12-20; most recent amendment 2026-04-27.
Status change: Recruiting → Active, Not Recruiting 2025-12-18
Status change: Not Yet Recruiting → Recruiting 2025-01-07
Trial Details
NCT Number NCT06752850
Lead Sponsor Swedish Orphan Biovitrum
Collaborators: PSI CRO
Conditions Haemophilia A (Moderate or Severe), Hemophilia, Classic, Haemophilia, Hemophilia, Classic Hemophilia, Synovial Hypertrophy
Enrollment 37 participants
Start Date 2024-12-19
Primary Completion 2026-11-17 (estimated)
Study Completion 2026-12-28 (estimated)
Updated on ClinicalTrials.gov 2026-04-30