Status:
NOT_YET_RECRUITING
Understanding Treatment Outcomes and Immunologic Mechanisms in Altuviiio Immune Tolerance Induction
Lead Sponsor:
Versiti Blood Health
Conditions:
Hemophilia A With Inhibitor
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 1\) severe hemophilia A (congenital) 2) history of high titer inhibitor (≥ 5 BU) 3) peak inhibitor titer (pre-ITI) \< 1,000 3) age \< 18 y/o at the time of study enrollment 4) undergoing initial ITI course 5) current or planned concomitant use of emicizumab
Exclusion
- von Willebrand disease or a known second bleeding diathesis besides SHA
- prior course of ITI
- inhibitor present for \> 2 years without prior attempts at eradication
- 3\) personal history of unprovoked thrombosis 4) known contraindication, intolerance, or allergy to either of the investigational agents of study 5) inability or unwillingness to provide informed consent and/or assent 6) inability to speak or read English 7) Any other condition, that in the opinion of the investigator, would negatively impact the safety of the participant
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2032
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT07158606
Start Date
October 1 2025
End Date
August 31 2032
Last Update
September 8 2025
Active Locations (1)
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1
Versiti Wisconsin
Milwaukee, Wisconsin, United States, 53226