drugset / Trial / NCT06752850

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

NCT06752850

Phase 4 Active not recruiting 37 enrolled Swedish Orphan Biovitrum PSI CRO · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-12-19
Primary completion
2026-11-17
Completion
2026-12-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Efanesoctocog alfa Protein / enzyme biologic 50 iu/kg Intravenous

Indications