Early Signals of the Transition From Immune Quiescence to Activation in the Liver Allograft Microenvironment and in the Circulation
Recruiting
Phase 2Interventional Study
Liver Transplant
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
3 – 13
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID) · NIH
Who this trial is looking for
This trial is looking for children aged 3 to 7 years who have received a liver transplant. Participants will reduce their immunosuppression medication by half and will undergo regular liver tests over 18 months to see how well they do.
Are You a Good Fit for This Trial?
Must be takingTacrolimus
You may be able to join if
I am a child between 3 and 7 years old who had a liver transplant.
I have stable liver test results.
I have not had acute or chronic rejection in the past year.
I have been taking tacrolimus for more than 6 months.
I can provide informed assent, and my parent or guardian can give consent.
If I can get pregnant, I have a negative pregnancy test.
You may not be able to join if
I had a liver transplant for an autoimmune disease.
I had a liver transplant for hepatitis B or C.
I have received another organ transplant.
I have had a significant increase in tacrolimus dosage recently.
I have an active or chronic infection needing treatment.
I have a systemic illness that needs ongoing immunosuppression.
I am unable or unwilling to follow the study's rules.
I have used an investigational drug in the past month.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 scr…
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)
Trial Locations
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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. S…
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
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