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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 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.
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)
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07549503
The ClinicalTrials.gov registry entry for NCT07549503 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tacrolimus reduction is the first listed.
NCT07549503 reports 0 study locations.
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.
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