This study aims to understand how well Altuviiio (efanesoctacog alpha) works for Immune Tolerance Induction (ITI) in children and teenagers with severe hemophilia A (a bleeding disorder) who have developed inhibitors (antibodies that make treatment less effective). Participants will also receive Hemlibra (emicizumab) to prevent bleeding. The study is looking for individuals aged 0 to 17 years who have severe hemophilia A with a history of high-titer inhibitors and are starting their first ITI course. The main goal is to see if ITI is successful after 12 months. The study is currently unclear on its recruitment status and plans to enroll 15 participants.

Study design

This is an interventional study, not specifying a phase, and plans to enroll 15 participants. It is a single-arm study, meaning all participants receive the same treatment.

What's involved

You would have a screening visit up to 8 weeks before treatment, followed by a baseline visit and interim visits every 4 weeks for up to 52 weeks. Some interim visits may be done by phone.

Compensation

Not stated in the trial record.

Follow-up

ITI success will be measured at 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.