Understanding Treatment Outcomes and Immunologic Mechanisms in Altuviiio Immune Tolerance Induction

ClinicalTrials.gov ID: NCT07158606

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Official title

Understanding Treatment Outcomes and Immunologic Mechanisms in ALtuviiio Immune Tolerance Induction

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID: NCT07158606
Recruitment status: Not yet recruiting
Study type: Interventional
Phase: Phase 4
Lead sponsor: Versiti Blood Health; Other
Enrollment: 15 participants

Conditions and interventions

Conditions

Hemophilia A With Inhibitor

Interventions

efanesoctacog alpha Drug
Emicizumab Drug

Drug

Eligibility (public fields only)

Age range: 0 Years to 17 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 1, 2026 (Estimated)
Primary completion: Dec 31, 2031 (Estimated)
Completion: Aug 31, 2033 (Estimated)
Last update posted: Jul 27, 2026

2026 – 2033

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Versiti Wisconsin	Milwaukee	Wisconsin	53226	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07158606, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 27, 2026 · Synced Nov 12, 2026