NCT07158606Not yet recruitingPhase 4
Understanding Treatment Outcomes and Immunologic Mechanisms in Altuviiio Immune Tolerance Induction
Source: ClinicalTrials.gov · Last updated 27 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 28 Aug 2025
- Start date
- Dec 2026
- Primary completion date
- Dec 2031
- Lead sponsor
- Versiti Blood Health
- Diseases
- Haemophilia
- NCT number
- NCT07158606
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 15
- From Dec 2026 to the primary completion date, Dec 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- von Willebrand disease or a known second bleeding diathesis besides SHA
Who the study is looking for
- 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
Age in the registry: 0 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Versiti Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.