🏛️ Verified NIH Record • Updated 2026-06-05

Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation (NCT07549503)

Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation (RTB-018)

🟢 Recruiting Phase2 🩺 Clinical Procedure Protocol Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

🩺 Plain-English Summary (8th-Grade Level)

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)

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (12 items).

Location: UCSF Benioff Children's Hospital — San Francisco, California

Age range: 3 Years to 13 Years

🧪 Interventions in This Study

  • Tacrolimus reduction (PROCEDURE)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following apply:

  • Exclusion Criteria:
  • Liver transplant (LTx) for autoimmune disease, including autoimmune hepatitis or primary sclerosing cholangitis
  • LTx for hepatitis B or hepatitis C
  • Recipient of any other organ transplant or liver re-transplant, except for patients who have a repeat LTx within 30 days of first LTx who are eligible for enrollment
  • \>=50 percent dose increase in tacrolimus within 12 months of enrollment
  • Discontinued a second Immunosuppression (IS) agent within 12 months of enrollment
  • Systemic illness requiring chronic or recurrent use of IS for which there is a risk of reactivation if tacrolimus is reduced
  • Use of medication to treat systemic conditions which in the judgement of the investigator could influence results of the study
  • Active or chronic infection requiring treatment
  • Inability or unwillingness to comply with the study protocol
  • Use of investigational drug within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of enrollment
  • Has any condition that, in the opinion of the investigator, will interfere with safe participation in the trial

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (10 Sites)

  • UCSF Benioff Children's Hospital — San Francisco, California
  • Children's Hospital Colorado — Aurora, Colorado
  • MedStar Georgetown University Hospital — Washington D.C., District of Columbia
  • Emory University School of Medicine/Children's Healthcare of Atlanta — Atlanta, Georgia
  • Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
  • Icahn School of Medicine at Mount Sinai — New York, New York
  • Columbia University Medical Center — New York, New York
  • Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio
  • Children's Hospital of Philadelphia — Philadelphia, Pennsylvania
  • Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee

📞 Contact the Study Coordinator

Phone: (415) 353-7004

Email: ada.chao@ucsf.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗