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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: Clinical Trial Phase 4 study, sponsored by Versiti Blood Health.
NCT07158606 is a Phase 4 study that has not yet begun recruiting, run by Versiti Blood Health. The registered enrollment target is 15 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Time from initial dose of efanesoctacog alpha for ITI to ITI success or failure.
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 |
What is known before NCT07158606 opens enrollment
NCT07158606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which Emicizumab is the first listed.
NCT07158606 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07158606's enrollment target sits among peer trials
15 1880th of 2000 higher than 100 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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