What type of study is this?

This is a Pre-Registered Trial study.

December 8, 2025BloodOpen Access

Evaluating the safety and tolerability of switching from emicizumab to fitusiran prophylaxis in adult males with severe hemophilia A, with or without inhibitors: SWITCH study, a trial in progress

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Exploratory trial evaluating switching to fitusiran in adult males with severe hemophilia A, indicating safety concerns.

To evaluate the safety and tolerability of switching from emicizumab to fitusiran in severe hemophilia A.
Open-label, single-arm Phase 1 study with approximately 15-20 adult males.
Participants undergo a washout period followed by fitusiran prophylaxis for 18 months.
Monitoring includes thrombin generation, antithrombin levels, and adverse events.
Primary endpoint focuses on adverse events from Day 1 to Month 4 of fitusiran treatment.
Secondary endpoints include health-related quality of life, bleeding rates, and joint health assessments.
Modeling and simulations were used to establish the washout strategy and predict factor VIII-like activity.

Young et al. (2025) studied this question.

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