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NCT07549503 · ClinicalTrials.gov registry record · Phase 2
Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
NCT07549503: Recruiting Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT07549503 is a Phase 2 study that is actively recruiting participants, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 100 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07549503, a Phase 2 study, is actively recruiting participants, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
Study Summary
This is a prospective multi-center, longitudinal study to determine efficacy of 50 percent Immunosuppression (IS) reduction. One hundred fully eligible participants will reduce IS by 50 percent in two steps. Liver tests will be checked every 0.5 months through month 4, once a month through month 12, and every other month through month 18. Liver transplant (LTx) center visits will take place at screening, months 6, 12 and 18 after initiating IS dose reduction. A protocol driven liver biopsy to adjudicate the endpoint will be performed at 18 months. The duration of the study from time of starting IS dose reduction to the primary endpoint assessment is 18 months. The primary objective is to assess the efficacy of 50 percent IS dose reduction in children with Liver transplants (LTxs)
Primary Outcome
Defined as meeting both biochemical and histological criteria of stability
Interventions
- PROCEDURE Tacrolimus reduction
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-05-14 |
| Est. Completion | 2031-10-01 |
| Phase | Phase 2 |
What NCT07549503 shows while recruiting
NCT07549503 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% lower).
The record links to 0 conditions, and to 1 intervention - of which Tacrolimus reduction is the first listed.
NCT07549503 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07549503 about?
NCT07549503 is a clinical study titled "Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation". This is a prospective multi-center, longitudinal study to determine efficacy of 50 percent Immunosuppression (IS) reduction. One hundred fully eligible participants will reduce IS by 50 percent in two steps. Liver tests will be checked every 0.5 months through month 4, once a month through month 12,...
What is the current status of trial NCT07549503?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2026-05-14. Estimated completion is 2031-10-01.
What interventions are being tested in trial NCT07549503?
The interventions under investigation include: Tacrolimus reduction (PROCEDURE).
Who is sponsoring clinical trial NCT07549503?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07549503's enrollment target sits among peer trials
100 672nd of 2000 higher than 1,263 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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