Understanding Treatment Outcomes and Immunologic Mechanisms in Altuviiio Immune Tolerance Induction
Status:
NOT_YET_RECRUITING
Trial end date:
2032-08-31
Target enrollment:
Participant gender:
Summary
The goal of this clinical trial is to learn how well Altuviiio (efanesoctacog alpha) works for Immune Tolerance Induction (ITI) while using Hemlibra (emicizumab) to prevent bleeds.
Participants will be given Altuviiio for their ITI therapy and also be treated with Hemlibra as standard of care prophylaxis to prevent bleeding. The research doctor will decide how much and how often the participant will get Hemlibra.
Participants will need to attend visits for checkups and tests. These visits are divided into 4 periods:
1. A screening period - 1 visit up to 8 weeks before the Treatment Period starts
2. ITI Treatment Period - 1 Baseline Visit plus Interim visits that occur every 4 weeks for up to 52 weeks. (Some of the interim visits may be done via phone)
3. Tapering Period - 5 visits at weeks 2, 4, 8, 12 and 16
4. Ongoing Monitoring Period - 4 visits at weeks 20, 30, 40 and 50