Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation
Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation (RTB-018)
- Liver Transplant
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Enrolment target
- 100
- Started
- 14 May 2026
- Main results due
- 1 April 2031
- Study sites
- 11
- Registry updated
- 28 September 2026
Can you take part?
- Ages 3 years to 13 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: 1. Participant and parent or guardian must be able to understand and provide informed assent and consent, respectively 2. Recipient of a living or deceased donor Liver transplant (LTx) at \<7 years of age 3. \> 3 years but \<7 years after LTx at the time of study enrollment 4. Stable liver tests defined as baseline serum alanine aminotransferase (ALT) level \< 30 IU/l and gamma-glutamyl transferase (GGT) level \< 50 IU/l (based on the average of the 3 most recent values prior to screening; all must be within 1 year of screening; 2 must be within 6 months of screening) 5. No Acute rejection (AR) or chronic rejection within 12 months of enrollment 6. Tacrolimus monotherapy for \> 6 months with baseline 12-hour trough levels \<8 ng/mL (based on the average of 3 values prior to screening; all must be within 1 year of screening; 2 must be within 6 months of screening) 7. Participants of childbearing potential must have a negative pregnancy test upon study entry Exclusion Criteria: 1. Liver transplant (LTx) for autoimmune disease, including autoimmune hepatitis or primary sclerosing cholangitis 2. LTx for hepatitis B or hepatitis C 3. 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 4. \>=50 percent dose increase in tacrolimus within 12 months of enrollment 5. Discontinued a second Immunosuppression (IS) agent within 12 months of enrollment 6. Systemic illness requiring chronic or recurrent use of IS for which there is a risk of reactivation if tacrolimus is reduced 7. Use of medication to treat systemic conditions which in the judgement of the investigator could influence results of the study 8. Active or chronic infection requiring treatment 9. Inability or unwillingness to comply with the study protocol 10. Use of investigational drug within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of enrollment 11. Has any condition that, in the opinion of the investigator, will interfere with safe participation in the trial
What this study is about
In the sponsor’s own words, from the registry.
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)
Study sites(11)
UCSF Benioff Children's Hospital
San Francisco, California, United States
Recruiting
Children's Hospital Colorado
Aurora, Colorado, United States
Not yet recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Recruiting
Emory University School of Medicine/Children's Healthcare of Atlanta
Atlanta, Georgia, United States
Not yet recruiting
Ann and Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Recruiting
Columbia University Medical Center
New York, New York, United States
Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Not yet recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Recruiting
Monroe Carell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Not yet recruiting
Showing 11 of 11 sites. 7 of the 11 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07549503. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
Not the right study?
Answer three questions and see the studies recruiting near you, in plain language.
Find a study for me