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NCT07158606 · ClinicalTrials.gov registry record · Phase 4
Understanding Treatment Outcomes and Immunologic Mechanisms in Altuviiio Immune Tolerance Induction
A Phase 4 study, sponsored by Versiti Blood Health.
- Not yet
- Registry status
- Phase 4
- Development phase
- 15
- Enrollment target
NCT07158606 is a Phase 4 study that has not yet begun recruiting, run by Versiti Blood Health. The registered enrollment target is 15 participants.
The verdict
NCT07158606, a Phase 4 study, has not yet begun recruiting, sponsored by Versiti Blood Health.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 15 participants
- Enrollment target
Study 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 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
Interventions
- DRUG Emicizumab
- DRUG efanesoctacog alpha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-10-01 |
| Est. Completion | 2032-08-31 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07158606
The ClinicalTrials.gov registry entry for NCT07158606 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Versiti Blood Health, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Emicizumab is the first listed.
NCT07158606 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07158606 about?
NCT07158606 is a clinical study titled "Understanding Treatment Outcomes and Immunologic Mechanisms in Altuviiio Immune Tolerance Induction". 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 proph...
What is the current status of trial NCT07158606?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 15 participants. The study started on 2025-10-01. Estimated completion is 2032-08-31.
What interventions are being tested in trial NCT07158606?
The interventions under investigation include: Emicizumab (DRUG), efanesoctacog alpha (DRUG).
Who is sponsoring clinical trial NCT07158606?
This trial is sponsored by Versiti Blood Health, which has 3 total clinical trials registered on ClinicalTrials.gov.
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