Understanding Treatment Outcomes and Immunologic Mechanisms in Altuviiio Immune Tolerance Induction

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Versiti Blood Health
Study ID
NCT07158606
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Hemophilia A With Inhibitor

Eligibility Criteria

Sex
ALL
Age
0 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • efanesoctacog alpha — DRUG
    Efanesoctacog alpha will be administered at a dose of 50 IU/kg two times weekly during the ITI Treatment Period. The site investigator will determine the dose of efanesoctacog alpha once the subjects reaches the Follow Up Period.
  • Emicizumab — DRUG
    Emicizumab will be prescribed as standard of care bleed prevention.

Study Details

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

Key Dates

Start date
Oct 1, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2030
Completion
Aug 31, 2032

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ITI
    ITI therapy will involve subjects receiving efanesoctacog alpha at a determined dose.

Primary Outcome Measure

ITI Success [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Versiti WisconsinMilwaukeeWisconsin53226
Courtney Conway
[email protected]
414-257-2424
Megan Lemanczyk
414-257-2424
Lynn Malec, MD, MSc (PRINCIPAL_INVESTIGATOR)

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