๐Ÿ›๏ธ Verified NIH Record โ€ข 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)

๐ŸŸข Recruiting Phase2 ๐Ÿฉบ Clinical Procedure Protocol Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

๐Ÿฉบ 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: Review the eligibility criteria below.

Location: UCSF Benioff Children's Hospital โ€” San Francisco, California

Age range: 3 Years to 13 Years

๐Ÿงช Interventions in This Study

  • Tacrolimus reduction (PROCEDURE)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (10 Sites)

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

๐Ÿ“ž 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.

๐Ÿ’ฐ 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 ยง 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.

Explore by condition: All Liver Transplant clinical trials

๐Ÿ’ก 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.
๐Ÿ›๏ธ View Official NIH Record โ†—